Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 17-005123
    NCT ID: NCT02810704
    Sponsor Protocol Number: 17-005123

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Males and females 21 years of age or older;
  2. Undergoing elective primary or revision hip or knee replacement;
  3. Patient has necessary mental capacity to participate and is able to comply with study protocol requirements;
  4. Patient is not pregnant;
  5. Patient has signed consent form; and
  6. Patient is wiling to be randomized and participate.

Exclusion Criteria:

  1. Patient is undergoing bilateral hips or knee replacement;
  2. No patient undergoing total hip or knee replacement who has been enrolled in this study for a prior hip or knee replacement;
  3. Women who are pregnant or breastfeeding;
  4. Patient is on chronic anticoagulation other than with antiplatelet medications;
  5. Patient is concurrently enrolled in another active interventional clinical trial testing a drug or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;
  6. Patient has a contraindication to two or more of the three prophylaxis regimens;
  7. Documented gastrointestinal, cerebral, or other hemorrhage within 3 months of the operation;
  8. A known diagnosis of defective hemostasis and past history of clinical bleeding requiring transfusion and treatment;

7) A known condition of thrombophilia proven by diagnostic laboratory testing; 9) An operative procedure involving the eye, ear, or central nervous system within one month; 10) Severe uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg; 11) An absolute body weight of less than 41 kilograms (90.4 lbs) at baseline; and 12) Vulnerable patient populations including prisoners, institutionalized individuals, and those who are mentally handicapped.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Spangehl, M.D.

Open for enrollment

Contact information:

Saran Vaughn

(480)342-6487

Vaughn.Saran@mayo.edu

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CLS-20358112

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