Skip to content

A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02584660
Acronym
MERCURY PE
Enrollment
114
Registered
2015-10-22
Start date
2015-10-15
Completion date
2017-03-22
Last updated
2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

Rivaroxaban, JNJ39039039, Pulmonary embolism

Brief summary

The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.

Detailed description

This is a randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, multicenter (study conducted at multiple sites) study to evaluate that low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments. Safety will be monitored during the study.

Interventions

DRUGRivaroxaban

Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.

DRUGStandard-of-care

Standard-of-care as per local protocol and defined by the medical team caring for the participant.

Sponsors

Bayer
CollaboratorINDUSTRY
Janssen Scientific Affairs, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic deep vein thrombosis (DVT) * A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low risk of clinical deterioration as determined by the Hestia criteria * Have no contraindications to and be able to complete randomized treatment and all study assessments * Have a life expectancy of at least 6 months * Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion criteria

* Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450) inhibitors (such as but not limited to ketoconazole, telithromycin or protease inhibitors) use within 4 days before randomization, or planned use during the study. Itraconazole use within 7 days before randomization or planned use during the study * Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned use during the study * Who Has contraindications to the use of any anticoagulant therapy (example, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy documented at Screening) * Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients * Woman who is pregnant, or breast-feeding, or planning to become pregnant

Design outcomes

Primary

MeasureTime frameDescription
Mean Duration of HospitalizationUp to Day 30Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.

Secondary

MeasureTime frameDescription
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 7, 14, 30, and 90 DaysReoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 7, 14, 30 and 90 DaysPercentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any ReasonUp to 30 and 90 DaysMean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Day 90ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.
Percentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireDay 7The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.

Countries

United States

Participant flow

Pre-assignment details

Of the 300 participants screened, 114 participants were randomized (51 to rivaroxaban group and 63 participants in the standard-of-care group) and 112 participants were treated and received at least 1 dose of study agent.

Participants by arm

ArmCount
Rivaroxaban
Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.
51
Standard-of-care
Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
63
Total114

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event40
Overall StudyLost to Follow-up34
Overall StudyOther01
Overall StudyProtocol Violation01
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicRivaroxabanStandard-of-careTotal
Age, Continuous49.1 years
STANDARD_DEVIATION 13.27
47.6 years
STANDARD_DEVIATION 17.22
48.3 years
STANDARD_DEVIATION 15.53
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
47 Participants60 Participants107 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black or African American
20 Participants14 Participants34 Participants
Race/Ethnicity, Customized
Hispanic or Latino
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
47 Participants60 Participants107 Participants
Race/Ethnicity, Customized
Other
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
White
29 Participants48 Participants77 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
20 Participants14 Participants34 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
29 Participants48 Participants77 Participants
Region of Enrollment
UNITED STATES
51 Participants63 Participants114 Participants
Sex: Female, Male
Female
27 Participants32 Participants59 Participants
Sex: Female, Male
Male
24 Participants31 Participants55 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 63
other
Total, other adverse events
15 / 4913 / 63
serious
Total, serious adverse events
5 / 497 / 63

Outcome results

Primary

Mean Duration of Hospitalization

Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.

Time frame: Up to Day 30

Population: The intention to treat analysis set (ITT) included all participants who were randomized into the study.

ArmMeasureValue (MEAN)Dispersion
RivaroxabanMean Duration of Hospitalization0.191 DaysStandard Deviation 0.6862
Standard-of-careMean Duration of Hospitalization1.393 DaysStandard Deviation 1.9642
p-value: <0.000195% CI: [-1.73, -0.674]t-test
Secondary

Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason

Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.

Time frame: Up to 30 and 90 Days

Population: The ITT included all participants who were randomized into the study.

ArmMeasureGroupValue (MEAN)Dispersion
RivaroxabanMean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any ReasonWithin 30 Days0.679 DaysStandard Deviation 2.0894
RivaroxabanMean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any ReasonWithin 90 Days0.764 DaysStandard Deviation 2.1829
Standard-of-careMean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any ReasonWithin 30 Days1.513 DaysStandard Deviation 1.9952
Standard-of-careMean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any ReasonWithin 90 Days1.812 DaysStandard Deviation 2.714
Secondary

Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire

The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.

Time frame: Day 7

Population: The safety population included all randomized participants who took at least 1 dose of study drug.

ArmMeasureGroupValue (NUMBER)
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Neither4.2 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Neither4.2 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Very Dissatisfied0 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Quite Dissatisfied0 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Quite Satisfied33.3 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Very Dissatisfied0 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Very Satisfied62.5 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: In the Hospital18.8 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Quite Dissatisfied2.1 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: In the Community50 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Quite Satisfied33.3 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: No Preference31.3 Percentage of participants
RivaroxabanPercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Very Satisfied60.4 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: No Preference11.9 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Very Satisfied62.7 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Quite Satisfied23.7 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Neither6.8 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Quite Dissatisfied5.1 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireSatisfaction level: Very Dissatisfied1.7 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Very Satisfied59.3 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Quite Satisfied30.5 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Neither6.8 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Quite Dissatisfied1.7 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnaireLocation of care: Very Dissatisfied1.7 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: In the Hospital47.5 Percentage of participants
Standard-of-carePercentage of Participants Satisfied Using Site-of-Care Satisfaction QuestionnairePreference of care: In the Community40.7 Percentage of participants
Secondary

Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding

Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.

Time frame: Up to 7, 14, 30 and 90 Days

Population: The ITT included all participants who were randomized into the study.

ArmMeasureGroupValue (NUMBER)
RivaroxabanPercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 7 Days0 Percentage of Participants
RivaroxabanPercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 14 Days2 Percentage of Participants
RivaroxabanPercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 30 Days3.9 Percentage of Participants
RivaroxabanPercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 90 Days3.9 Percentage of Participants
Standard-of-carePercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 90 Days6.3 Percentage of Participants
Standard-of-carePercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 7 Days0 Percentage of Participants
Standard-of-carePercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 30 Days1.6 Percentage of Participants
Standard-of-carePercentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or BleedingUp to 14 Days0 Percentage of Participants
Secondary

Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death

Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.

Time frame: Up to 7, 14, 30, and 90 Days

Population: The ITT included all participants who were randomized into the study.

ArmMeasureGroupValue (NUMBER)
RivaroxabanPercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 7 Days0 Percentage of participants
RivaroxabanPercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 14 Days0 Percentage of participants
RivaroxabanPercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 30 Days0 Percentage of participants
RivaroxabanPercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 90 Days0 Percentage of participants
Standard-of-carePercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 90 Days0 Percentage of participants
Standard-of-carePercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 7 Days0 Percentage of participants
Standard-of-carePercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 30 Days0 Percentage of participants
Standard-of-carePercentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related DeathUp to 14 Days0 Percentage of participants
Secondary

Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)

ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.

Time frame: Day 90

Population: The safety population included all randomized participants who took at least 1 dose of study drug.

ArmMeasureGroupValue (NUMBER)
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: A little17.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Not at all60 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: A little33.3 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Moderately4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Not at all80 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Moderately0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Not at all75.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: A little20 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Moderately2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Not at all73.3 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: A little22.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Moderately4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Quite a bit0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Not at all82.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: A little15.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Moderately0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Not at all84.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: A little15.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Moderately0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Quite a bit0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Not at all48.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: A little28.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Moderately8.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Quite a bit11.1 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Extremely2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Not at all77.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: A little17.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Moderately4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Quite a bit0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Not at all84.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: A little15.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Moderately0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Quite a bit0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Not at all64.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: A little28.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Moderately4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Not at all4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: A little8.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Moderately20 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Quite a bit26.7 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Extremely40 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Not at all4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: A little8.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Moderately20 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Quite a bit35.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Extremely31.1 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Not at all8.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: A little2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Moderately15.6 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Quite a bit33.3 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Extremely40 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Not at all2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: A little13.3 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Moderately17.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Quite a bit28.9 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Extremely37.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Not at all51.1 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: A little40 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Moderately6.7 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Not at all77.8 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: A little13.3 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Moderately6.7 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Quite a bit2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Extremely0 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Not at all71.1 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: A little22.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Moderately2.2 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Quite a bit4.4 Percentage of participants
RivaroxabanTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Extremely0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Quite a bit1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: A little16.4 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Extremely1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Moderately9.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Not at all52.7 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Quite a bit45.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: A little20 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Quite a bit3.7 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Moderately9.1 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: A little21.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Quite a bit10.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Extremely3.7 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 4: Extremely7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Extremely30.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Not at all60 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Not at all54.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Moderately16.4 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Extremely3.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Quite a bit7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: A little18.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 5: Extremely0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Not at all7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Not at all56.4 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Moderately14.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: A little25.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Extremely1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Moderately5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Quite a bit7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Quite a bit12.7 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: A little7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 6: Extremely0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 13: Extremely5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Not at all45.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Not at all70.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: A little30.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Not at all5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Moderately20 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Moderately18.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Quite a bit1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: A little7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 7: Extremely1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Quite a bit5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Not at all78.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Moderately21.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: A little12.7 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Quite a bit43.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Moderately7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Quite a bit38.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Quite a bit1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: A little20 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 8: Extremely0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 14: Extremely27.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Not at all74.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 17: Extremely23.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: A little21.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Not at all5.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Moderately1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Not at all65.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Quite a bit1.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: A little5.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 9: Extremely0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Not at all61.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Not at all43.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Moderately24.1 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: A little16.4 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Moderately7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Moderately18.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Quite a bit42.6 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Quite a bit10.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: A little21.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 10: Extremely10.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 15: Extremely22.2 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Not at all60 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 3: Moderately5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: A little16.4 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Not at all5.5 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Moderately7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 1: Moderately10.9 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Quite a bit9.1 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: A little9.1 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 11: Extremely7.3 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 2: Quite a bit0 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: Not at all64.8 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 16: Moderately9.1 Percentage of participants
Standard-of-careTreatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)Item 12: A little18.5 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026