Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:2/3/2019
Start Date:December 2016
End Date:February 2021
Contact:Carol A Lambourne, PhD
Email:lambourc@musc.edu
Phone:843-792-2913

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Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement: Balancing Safety and Effectiveness

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.

PEPPER is a large pragmatic clinical trial to inform patient choice and balance risk
tolerances of individuals who face decisions about different drugs and strategies for deep
vein thrombosis (DVT) and pulmonary embolism (PE) prevention after total hip (THA) and knee
(TKA) replacement. Indeed, clinical equipoise exists to ethically support such a randomized
trial that has great potential to change current practice. We have selected the three
prophylaxis methods that represent current orthopaedic practice in North America and
collectively account for more than 80% of all hip and knee replacements; a) enteric coated
aspirin (regimen with lowest bleeding risk; clinical PE and all-cause mortality rates
comparable to more intensive anticoagulants), b) low intensity (INR Target 2.0) warfarin
(time honored and one of the most common North American regimens; low bleeding risk [1-2%]),
and c) rivaroxaban, a new oral direct Factor Xa inhibitor (regimen with lowest PE and DVT
rate but higher bleeding risk [3-5%]). Prophylaxis will continue for 30 days, in accordance
with clinical guidelines, and pneumatic compression will be utilized in hospital in
conjunction with each treatment group. Each regimen is commonly used in contemporary
practice, supported by observational and clinical trial data, and endorsed by the American
College of Chest Physicians (ACCP) and American Academy of Orthopaedic Surgeons (AAOS)
guidelines

Inclusion Criteria:

1. 21 years of age or older;

2. Undergoing elective primary, revision or second stage re-implantation total hip/knee
replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;

3. Has necessary mental capacity to participate and is able to comply with study protocol
requirements;

4. Eligible for randomization to at least two of the three study regimens;

5. Is not pregnant on the day of surgery;

6. Has signed the consent form; and

7. Is willing to be randomized and participate in the study.

Exclusion Criteria:

1. Undergoing bilateral hip or knee replacement;

2. Has been previously enrolled;

3. Is pregnant or breastfeeding;

4. Is on chronic anticoagulation other than antiplatelet medications;

5. Concurrently enrolled in another active interventional clinical trial testing a drug
or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;

6. Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;

7. Has a known diagnosis of defective hemostasis and past history of clinical bleeding
requiring transfusion and treatment;

8. Has had an operative procedure involving the eye, ear, or central nervous system
within one month;

9. Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;

10. Body weight of less than 41 kilograms at baseline visit;

12) Member of a vulnerable patient population.
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Scottsdale, Arizona 85259
Principal Investigator: Mark Spangehl, MD
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Robert Sterling, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Michael Mont, MD
Phone: 216-444-4954
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: C. Lowry Barnes, MD
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Navin D Fernando, MD, FRCSC
Phone: 206-520-5740
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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2501 Parkers Lane
Alexandria, Virginia 22306
Principal Investigator: Kevin Fricka, MD
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Baltimore, Maryland 21215
Principal Investigator: James Nace, MD
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Principal Investigator: Lawrence Specht, MD
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Richard Friedman, MD
Phone: 843-792-8169
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: James Browne, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Joshua Jacobs, MD
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Michael Suk, MD
Phone: 570-214-6178
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Hershey, Pennsylvania 17033
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Wayne Moschetti, MD
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London, Ontario
Principal Investigator: Brent Lanting, MD
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Brock Lindsey, MD
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Richard Iorio, MD
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Kevin Garvin, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Charles L Nelson, MD
Phone: 267-207-6254
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
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Rochester, Minnesota 55905
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Santa Monica, California 90404
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6141 Sunset Drive
South Miami, Florida 33143
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Stanford, California 94303
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