Phase 3
Completed N=3,365
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Source: ClinicalTrials.gov NCT02064439 ↗Enrolled (actual)
3,365
Serious AEs
7.1%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism — 13; 17; 50; 8 participants — p=0.0001
◆ Published Evidence
Highly cited
771citations · ~86 / year
Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.
Summary
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.
Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Linked Publications (5)
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Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.
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Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.
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Antiplatelet agents for the treatment of deep venous thrombosis.
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Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism.
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Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism |
13; 17; 50; 8; 9; 29 | 0.0001 sig |
| PRIMARY Number of Participants With First Treatment-emergent Major Bleeding |
5; 6; 3; 0; 1; 1 | 0.3235 |
| SECONDARY Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism |
18; 19; 56; 4; 2; 2 | <0.0001 sig |
| SECONDARY Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days |
12; 17; 12 | 0.3318 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min
Data sourced from ClinicalTrials.gov (NCT02064439) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.