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Antiplatelet Agent

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

Q: What maladies is Warfarin most often employed to combat?

<p>Warfarin is traditionally used to treat <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, but it has also been known to be effective in treating other medical issues such as myocardial infarction, catarrh, and fractures or broken bones.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months of operation

Awards & highlights

PEPPER Trial 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.

PEPPER Trial 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.

PEPPER Trial 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

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

PEPPER 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,523,339 Total Patients Enrolled

1 Trials studying Pulmonary Embolism

14 Patients Enrolled for Pulmonary Embolism

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,977,458 Total Patients Enrolled

3 Trials studying Pulmonary Embolism

436,463 Patients Enrolled for Pulmonary Embolism

University of Maryland, BaltimoreOTHER

688 Previous Clinical Trials

354,656 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its blessing to Warfarin?

"Given the late-stage of this clinical trial, Warfarin's safety rating is at a 3 due to approval and multiple rounds of data supporting its efficacy."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative, according to clinicaltrials.gov this medical experiment is actively searching for participants. Initially posted on December 1st 2016 and last revised November 3rd 2022, the trial calls for 20,000 individuals from 22 different centres."

Answered by AI

Is there any availability for participants in this experiment?

"Per the information hosted on clinicaltrials.gov, this medical study is actively searching for patients to participate in the trial. The research project was initially published on December 1st 2016 and it has been recently updated November 3rd 2022."

Answered by AI

Is this a pioneering endeavor in the medical field?

"Warfarin has been subject to clinical trials since 2005, with its first trial sponsored by Abbott. Following this initial 15480-patient study, Warfarin was given Phase 4 drug approval. Currently, 227 research projects are underway for Warfarin in 62 countries and over 1500 cities worldwide."

Answered by AI

Have there been prior research initiatives that have employed Warfarin?

"Warfarin was first investigated in 2005 by the Clinical Trial Service Unit of NDPH, University of Oxford. Currently, 879 clinical trials based on Warfarin have been completed and 227 are actively recruiting with many located in Omaha, Nebraska."

Answered by AI

In what capacity is this clinical study being monitored across multiple sites?

"This trial is available at 22 sites, including the University of Nebraska Medical Centre in Omaha, University of Virginia's location in Charlottesville and West virginia University in Morgantown. Other locations are also participating."

Answered by AI

What maladies is Warfarin most often employed to combat?

"Warfarin is traditionally used to treat pain, but it has also been known to be effective in treating other medical issues such as myocardial infarction, catarrh, and fractures or broken bones."

Answered by AI