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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Approved for 20 Other Conditions

All Individual Drugs Already Approved

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months of operation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aggregate primary clinical endpoints of all-cause mortality plus PE and DVT

Patient Well- Being

Specific Joint Function

+1 more

Secondary study objectives

"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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 10Eligibility criteria met