Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

About

Brief 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.

Primary Purpose

Supportive Care

Study Type

Interventional

Phase

Phase 4

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

21 Years

Maximum Age

N/A

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;
Has a known diagnosis of defective hemostasis and past history of clinical bleeding requiring transfusion and treatment;
Has had an operative procedure involving the eye, ear, or central nervous system within one month;
Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;
Body weight of less than 41 kilograms at baseline visit;
Member of a vulnerable patient population.

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