Blood thinner fails to boost dialysis fistula success in large trial
NCT ID NCT03289520
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether clopidogrel, a blood thinner, could prevent early failure of arteriovenous fistulas in 877 people with kidney failure starting hemodialysis. While clopidogrel reduced the risk of fistula clotting, it did not improve the chance that the fistula would be usable for dialysis. The results suggest that preventing clots alone is not enough to ensure a working fistula.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clopidogrel
- What this could lead to
- If successful, clopidogrel could help keep fistulas open longer, reducing the need for repeat surgeries and improving dialysis access reliability.
- What could go wrong
- The trial found that while clopidogrel reduced early fistula clotting, it did not increase the number of fistulas suitable for dialysis. This limits its practical benefit. Also, as a blood thinner, it carries bleeding risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
877 people
The number who actually took part.
- Started
-
Jan 2003
- Finished
-
Jun 2007
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Fistula Study Protocol Inclusion Criteria: * Age 18-21 depending on state regulations * 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: * Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston University Medical Center
Boston, Massachusetts, 02118, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Maine Medical Center
Portland, Maine, 04102, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Texas Southwestern
Dallas, Texas, 75390, United States
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Vanderbilt University
Nashville, Tennessee, 37232, United States
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Wake Forest University
Winston-Salem, North Carolina, 27157, United States
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Washington University
St Louis, Missouri, 63110, United States
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