Phase 3
N=3,365
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Pulmonary Embolism · Thromboembolism · Thrombosis · Venous Thrombosis · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT02064439 ↗Enrolled (actual)
3,365
Serious AEs
7.1%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism — 13; 17; 50; 8 participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BAY 59-7939 (Drug); ASA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2016
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 |
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
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). 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.