Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

Non-interventional Study Describing Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02839746

Enrollment

671

Registered

2016-07-21

Start date

2016-06-13

Completion date

2018-10-10

Last updated

2019-11-01

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

Conditions

Atrial Fibrillation

Brief summary

Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Written informed consent prior to participation * Female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation. * At least 6 months of continuous vitamin K antagonist (VKA) treatment for stroke prevention prior to baseline assessment. * Patients switched to Pradaxa® according to Summary of Product Characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.

Exclusion criteria

* Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC) * Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in non-valvular atrial fibrillation. * Current participation in any clinical trial of a drug or device

Design outcomes

Primary

Measure	Time frame	Description
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)	The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD).
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD).
Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD).

Secondary

Measure	Time frame	Description
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration	Baseline	Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.
Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®	Baseline	Categories of reasons for switching from VKAs to Pradaxa® are as below: 1. Hypersensitivity (Hypersensitivity to the drug) 2. Intracranial haemorrhage (Patients with a history of intracranial haemorrhage (ICH) (except during the acute phase) in whom the benefits of anticoagulation were deemed to outweigh the risk of haemorrhage) 3. Ischaemic stroke (Patients with ischaemic stroke who present clinical and neuroimaging criteria indicating a high risk of ICH) 4. Arterial thromboembolic episodes (Patients undergoing treatment with VKAs, suffering from severe arterial thromboembolic episodes despite good INR control) 5. INR not in range (Patients who have started treatment with VKAs in whom it is not possible to keep the INR in range (2-3) despite good therapeutic compliance) 6. INR management (Lack of access to conventional INR management) 7. Pts decision (Patient's decision) 8. Others. A single patient may have specified more than one reason
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score	Baseline	CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (\<60% of time within therapeutic range),Elderly (\>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score & HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED.
Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below: 1\] High risk of bleeding 2\] Moderate renal failure 3\] \>80 years 4\] Other reason
Reasons for no Longer Receiving Pradaxa® Treatment	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for no longer receiving Pradaxa® treatment categorized as below: 1. Treatment change (Change of treatment (by patient or by investigator) 2. Adverse event (Diarrhea, gastrointestinal discomfort, rectorrhagia, dyspepsia) 3. Exitus 4. Others
Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below: 1\] High risk of bleeding 2\] Moderate renal failure 3\] \>80 years 4\] Other reason
Patient Characteristics at Baseline - Categorical Parameters	Baseline	Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP). Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female). Stages of kidney disease are categorized based on Cockcroft-Gault review as below: No kidney failure (\> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (\< 15 ml/min).
Patient Characteristics at Baseline - Creatinine Clearance	Baseline	Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

Countries

Spain

Participant flow

Recruitment details

The data collection periods: * When planned to be switched from vitamin K antagonists (VKA) to Pradaxa® (At baseline, Visit 1) * 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2) * 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) Questionnaire (quest.)

Pre-assignment details

All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Not met selection criteria	12

Baseline characteristics

Characteristic	Total
Age, Continuous	73.12 Years STANDARD_DEVIATION 9.39
Race/Ethnicity, Customized Caucasian	638 Participants
Race/Ethnicity, Customized Latin American	19 Participants
Race/Ethnicity, Customized North African	2 Participants
Sex: Female, Male Female	275 Participants
Sex: Female, Male Male	384 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	8 / 653
other Total, other adverse events	0 / 653
serious Total, serious adverse events	14 / 653

Outcome results

Primary

Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment

The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD).

Time frame: When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)

Population: Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. as-treated analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included

Arm	Measure	Group	Value (MEAN)	Dispersion
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	Convenience-Baseline	60.19 Units on Scale	Standard Deviation 25.59
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	Convenience-Visit 3	84.29 Units on Scale	Standard Deviation 15.19
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	Satisfaction-Baseline	49.44 Units on Scale	Standard Deviation 17.74
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	Satisfaction-Visit 3	73.19 Units on Scale	Standard Deviation 14.8

Comparison: Within group comparison of Baseline convenience with that of Visit 3.p-value: <0.0001non-parametric Wilcoxon signed-rank

p-value: <0.0001non-parametric Wilcoxon signed-rank]

Primary

Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment

The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD).

Time frame: When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)

Population: Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. as-treated analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included

Arm	Measure	Group	Value (MEAN)	Dispersion
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	Convenience-Baseline	59.86 Units on Scale	Standard Deviation 25.39
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	Convenience-Visit 2	80.96 Units on Scale	Standard Deviation 16.98
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	Satisfaction-Baseline	49.15 Units on Scale	Standard Deviation 17.88
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	Satisfaction-Visit 2	69.35 Units on Scale	Standard Deviation 14.26

Comparison: Within group comparison of Baseline convenience with that of Visit 2.p-value: <0.0001non-parametric Wilcoxon signed-rank

Comparison: Within group comparison of Baseline satisfaction with that of Visit 2.p-value: <0.0001non-parametric Wilcoxon signed-rank

Primary

Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment

The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD).

Time frame: 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)

Population: Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. as-treated analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included

Arm	Measure	Group	Value (MEAN)	Dispersion
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	Convenience-Visit 2	80.95 unit on scale	Standard Deviation 17.01
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	Convenience-Visit 3	84.23 unit on scale	Standard Deviation 15.24
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	Satisfaction-Visit 2	69.54 unit on scale	Standard Deviation 14.22
Dabigatran Etexilate (Pradaxa®)	Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	Satisfaction-Visit 3	73.30 unit on scale	Standard Deviation 14.66

Comparison: Within group comparison of visit 2 convenience with that of Visit 3.p-value: <0.0001non-parametric Wilcoxon signed-rank

Comparison: Within group comparison of visit 2 satisfaction with that of Visit 3.p-value: <0.0001non-parametric Wilcoxon signed-rank

Secondary

Patient Characteristics at Baseline - Categorical Parameters

Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP). Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female). Stages of kidney disease are categorized based on Cockcroft-Gault review as below: No kidney failure (\> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (\< 15 ml/min).

Time frame: Baseline