Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus aspirin in the long-term prevention of blood clots from reccuring in the leg or lung

Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism The Einstein Choice Study - Reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic VTE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000619-26-BE

Enrollment

2850

Registered

2013-12-10

Start date

2014-06-11

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism MedDRA version: 14.1 Level: PT Classification code 10051055 Term: Deep vein thrombosis System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: HLT Classification code 10037439 Term: Pulmonary thrombotic and embolic conditions System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Leve

Interventions

Trade Name: Xarelto 10 mg Product Name: Rivaroxaban 10 mg Product Code: BAY 59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week. 2. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1425 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1425

Exclusion criteria

Exclusion criteria: 1. Legal lower age limitations (country specific) 2. Indication for therapeutic-dosed anticoagulants 3. Hypersensitivity to investigational or comparator treatment 4. Any other contraindication listed in the local labeling for investigational or comparator treatment 5. Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) 6. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk 7. Calculated creatinine clearance < 30 mL/min 8. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy 9. Life expectancy <6 months 10. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically 11. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 12. Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to acetylsalicylic acid (ASA) 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism). The principal safety objective is to document the incidence of the principal safety outcome (i.e. major bleeding). ;Secondary Objective: The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke, systemic non-central nervous system [CNS] embolism). The secondary safety objective is to document the incidence of the secondary safety outcome (i.e. clinically relevant non-major bleeding). ;Primary end point(s): Fatal or non-fatal symptomatic recurrent venous thromboembolism ;Timepoint(s) of evaluation of this end point: Composite efficacy outcomes will be analyzed based on time to first event in the intended 12-month treatment period, using a stratified (for index DVT only and index PE± DVT) Cox proportional hazard model in the full analysis set (FAS). Adjudication results will be the basis for the final analyses. The primary efficacy analysis will use a hierarchical (fixed sequence) testing procedure for testing superiority of the individual rivaroxaban doses vs. ASA.	—

Measure

Time frame

Main Objective: The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to acetylsalicylic acid (ASA) 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism). The principal safety objective is to document the incidence of the principal safety outcome (i.e. major bleeding). ;Secondary Objective: The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke, systemic non-central nervous system [CNS] embolism). The secondary safety objective is to document the incidence of the secondary safety outcome (i.e. clinically relevant non-major bleeding). ;Primary end point(s): Fatal or non-fatal symptomatic recurrent venous thromboembolism ;Timepoint(s) of evaluation of this end point: Composite efficacy outcomes will be analyzed based on time to first event in the intended 12-month treatment period, using a stratified (for index DVT only and index PE± DVT) Cox proportional hazard model in the full analysis set (FAS). Adjudication results will be the basis for the final analyses. The primary efficacy analysis will use a hierarchical (fixed sequence) testing procedure for testing superiority of the individual rivaroxaban doses vs. ASA.

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Secondary

Measure	Time frame
Secondary end point(s): fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke, systemic non-central nervous system [CNS] embolism;Timepoint(s) of evaluation of this end point: The secondary composite outcome will be analyzed with Cox regression and with log rank test as described for the primary efficacy analysis.	—

Countries

Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026