Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement (NCT02810704) | Clinical Trial Compass
CompletedPhase 4
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement
United States18,883 participantsStarted 2016-12
Plain-language summary
PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 21 years of age or older;
✓. Undergoing elective primary, revision or second stage re-implantation total hip/knee replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;
✓. Has necessary mental capacity to participate and is able to comply with study protocol requirements;
✓. Eligible for randomization to at least two of the three study regimens;
✓. Is not pregnant on the day of surgery;
✓. Has signed the consent form; and
✓. Is willing to be randomized and participate in the study.
Exclusion criteria
✕. Undergoing bilateral hip or knee replacement;
✕. Has been previously enrolled;
✕. Is pregnant or breastfeeding;
✕. Is on chronic anticoagulation other than antiplatelet medications;
✕. Concurrently enrolled in another active interventional clinical trial testing a drug or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;
✕. Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;
What they're measuring
1
Aggregate primary clinical endpoints of all-cause mortality plus PE and DVT
Timeframe: Within 6 months of operation
2
The frequency and nature of bleeding complications