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
- Conditions
- Symptomatic venous tromboembolism / Blood clots10014523
- Registration Number
- NL-OMON41605
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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 CYP3A4 and 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy objective is to evaluate whether rivaroxaban, in doses of<br /><br>10 mg or 20 mg, is superior to ASA 100 mg in the prevention of the primary<br /><br>efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous<br /><br>thromboembolism).<br /><br><br /><br>The principal safety objective is to document the incidence of the principal<br /><br>safety outcome (i.e. major bleeding).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and<br /><br>rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary<br /><br>efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous<br /><br>thromboembolism, myocardial infarction, ischemic stroke, systemic non-CNS<br /><br>embolism).<br /><br><br /><br>The secondary safety objective is to document the incidence of the secondary<br /><br>safety outcome (i.e. clinically relevant non-major bleeding).<br /><br><br /><br>Additional study objectives are to evaluate<br /><br>a. the composite of non-fatal symptomatic venous thromboembolism and all cause<br /><br>mortality<br /><br>b. the composite of major bleeding and recurrent venous thromboembolism<br /><br>c. the composite of major bleeding, recurrent venous thromboembolism,<br /><br>myocardial infarction, ischemic stroke and systemic non-CNS embolism</p><br>