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Antiplatelet Agent

Blood Thinners for Pulmonary Embolism Prevention After Hip and Knee Replacement (PEPPER Trial)

Phase 4
Recruiting
Led By Vincent D Pellegrini, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Undergoing bilateral hip or knee replacement
Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of operation
Awards & highlights

Summary

This trial is comparing 3 blood thinners to see which one is most effective in preventing blood clots after hip or knee surgery.

Who is the study for?
This trial is for adults over 21 who are having hip or knee replacement surgery and can follow the study plan. They must be able to take at least two of the medications being tested, not be pregnant, and weigh more than 41 kg. People with recent serious bleeding, uncontrolled high blood pressure, or on other trials that affect these drugs can't join.Check my eligibility
What is being tested?
The PEPPER study is randomly assigning patients undergoing joint replacement surgery to one of three blood thinners: enteric coated aspirin, low intensity warfarin, or rivaroxaban. It aims to find out which is best at preventing clots without causing problems.See study design
What are the potential side effects?
Possible side effects include bleeding in various parts of the body like stomach or brain (especially if you fall), allergic reactions, liver issues with warfarin needing regular blood tests to check levels, and potential spinal column bleeding if using rivaroxaban during certain procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I am scheduled for a hip/knee replacement or hip resurfacing surgery.
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I am eligible for at least two of the study's treatment options.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having surgery to replace both my hips or knees.
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My blood pressure is not higher than 220/120 mmHg.
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I have a bleeding disorder that has required blood transfusions and treatment.
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My weight is under 41 kilograms.
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I have had bleeding in my stomach, brain, or elsewhere in the last 3 months.
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I am not in a trial that tests drugs interacting with aspirin, warfarin, or rivaroxaban.
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I am on long-term blood thinners other than aspirin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months of operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months of operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aggregate primary clinical endpoints of all-cause mortality plus PE and DVT
Patient Well- Being
Specific Joint Function
+1 more
Secondary outcome measures
"Standard of care" methods of anesthesia on clinical effectiveness of three different prophylaxis regimens based on adverse events
Comparative frequency of thromboembolic events and bleeding complications occurring after hip and knee replacement

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: Rivaroxaban Other Names: XareltoExperimental Treatment1 Intervention
Rivaroxaban 10 mg will be first administered approximately 24 hours after completion of the index operation. Medication will then be administered in the evening on postoperative day #2 and thereafter each evening until completion.
Group II: Arm 2: Warfarin Other Names: CoumadinExperimental Treatment1 Intervention
Warfarin will be administered starting on the day of operation, prior to surgery, with a sip of water. The initial dose will be empirically determined by body weight: less than 125 lbs (56.7 kg) - 2.5 mg; 125-250 lbs (56.7-113.4 kg) - 5 mg; greater than 250 lbs (113.4 kg) - 7.5mg. The initial dose will be repeated on the evening of surgery if the preoperative dose was administered prior to noon on the day of operation; no warfarin will be given on the evening of surgery if the preoperative dose was received after noon on the day of operation. Thereafter, starting on postoperative day #1, warfarin will be given each evening based on INR values to achieve a target of 2.0 (range 1.7-2.2).
Group III: Arm 1: Enteric Coated AspirinExperimental Treatment1 Intervention
Enteric coated aspirin (162 mg po) will be administered on the day of operation, prior to surgery, with a sip of water. Thereafter, starting on postoperative day #1, all patients in the aspirin group will receive 81 mg po bid to complete the treatment period of 30 days. Patients on preoperative cardiac dose aspirin may continue their usual dosing regimen prior to the morning of surgery, and then commence the PEPPER trial aspirin dose of 81 mg po bid on the day after operation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Warfarin
FDA approved
Rivaroxaban
FDA approved

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
530 Previous Clinical Trials
2,524,934 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
14 Patients Enrolled for Pulmonary Embolism
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,972,150 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
436,463 Patients Enrolled for Pulmonary Embolism
University of Maryland, BaltimoreOTHER
695 Previous Clinical Trials
357,031 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
331 Patients Enrolled for Pulmonary Embolism

Media Library

Enteric Coated Aspirin (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02810704 — Phase 4
Pulmonary Embolism Research Study Groups: Arm 2: Warfarin Other Names: Coumadin, Arm 1: Enteric Coated Aspirin, Arm 3: Rivaroxaban Other Names: Xarelto
Pulmonary Embolism Clinical Trial 2023: Enteric Coated Aspirin Highlights & Side Effects. Trial Name: NCT02810704 — Phase 4
Enteric Coated Aspirin (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02810704 — Phase 4
Pulmonary Embolism Patient Testimony for trial: Trial Name: NCT02810704 — Phase 4
~2136 spots leftby Jul 2025