Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis
NCT ID: NCT03289520
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
877 participants
INTERVENTIONAL
2003-01-07
2007-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Clopidogrel
Clopidogrel
Placebo
Placebo
Interventions
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Clopidogrel
Placebo
Eligibility Criteria
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Inclusion Criteria
* Life expectancy of at least six months
* Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
* Planned creation of native upper extremity AV fistula
* The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months.
* The patient is expected to stay at a participating dialysis facility for at least 6 months.
* The patient's physician(s) will allow the patient to participate.
* Ability to give informed consent.
Exclusion Criteria
* The presence of ongoing bleeding.
* The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
* Recent bleeding episode requiring transfusion within 12 weeks of entry.
* The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
* A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or nonsteroidal anti-inflammatory drugs during the six week study drug administration period. Use of heparin during dialysis is allowed.
* Required use of oral or intravenous glucocorticoids at a dose greater than the equivalent of prednisone 15 mg per day during the six week study drug administration period.
* Current unstable angina.
* Required use of clopidogrel.
* Known hypersensitivity to clopidogrel.
* Medical considerations making anti-platelet therapy dangerous.
* Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.
* Baseline platelet count less than 75,000/mm3.
* Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices.
* Current problem with substance abuse.
* Concurrent participation in another medical intervention trial.
* Anticipated non-compliance with medical care based on physician judgment.
* Patient refusal.
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Boston University
OTHER
Duke University
OTHER
University of Iowa
OTHER
MaineHealth
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Alabama at Birmingham
OTHER
Washington University School of Medicine
OTHER
Baystate Medical Center
OTHER
Vanderbilt University
OTHER
CAMC Health System
OTHER
Emory University
OTHER
St. Louis University
OTHER
Tyler Nephrology Associates
UNKNOWN
Vascular Surgery Associates LLC
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Catherine Meyers, M.D.
Role: STUDY_DIRECTOR
NIDDK - Telephone: 301-451-4901; Email: [email protected]
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Iowa
Iowa City, Iowa, United States
Maine Medical Center
Portland, Maine, United States
Boston University Medical Center
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Countries
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References
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Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.
Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Other Identifiers
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DAC Fistula
Identifier Type: -
Identifier Source: org_study_id
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