Trial Search Results

Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Medical University of South Carolina

Collaborator: Northwestern University Feinberg School of Medicine

Stanford Investigator(s):

Intervention(s):

  • Drug: Enteric Coated Aspirin
  • Drug: Warfarin
  • Drug: Rivaroxaban

Phase:

Phase 4

Eligibility


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;

12) Member of a vulnerable patient population.

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
William Maloney
Not Recruiting