Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center; Medical University of South Carolina
• Collaborators: Brigham and Women's Hospital; Medical University of South Carolina; Northwestern University; Patient-Centered Outcomes Research Institute; University of Maryland; University of Maryland, Baltimore; University of Massachusetts, Worcester
• Treatments: Aspirin; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

1. 21 years of age or older;

2. Undergoing elective primary, revision or second stage re-implantation total hip/knee replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;

3. Has necessary mental capacity to participate and is able to comply with study protocol requirements;

4. Eligible for randomization to at least two of the three study regimens;

5. Is not pregnant on the day of surgery;

6. Has signed the consent form; and

7. Is willing to be randomized and participate in the study.

Exclusion Criteria:

1. Undergoing bilateral hip or knee replacement;

2. Has been previously enrolled;

3. Is pregnant or breastfeeding;

4. Is on chronic anticoagulation other than antiplatelet medications;

5. Concurrently enrolled in another active interventional clinical trial testing a drug or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;

6. Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;

7. Has a known diagnosis of defective hemostasis and past history of clinical bleeding requiring transfusion and treatment;

8. Has had an operative procedure involving the eye, ear, or central nervous system within one month;

9. Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;

10. Body weight of less than 41 kilograms at baseline visit;

11. Member of a vulnerable patient population.