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Blood thinner fails to boost dialysis fistula success in large trial

NCT ID NCT03289520

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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