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

Phase 1

• Conditions: ong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism; MedDRA version: 19.0Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 19.0Level: HLTClassification code 10037439Term: Pulmonary thrombotic and embolic conditionsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: HLTClassification code 10034572Term: Peripheral embolism and thrombosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 19.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000619-26-SE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-30
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2850

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified