Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis (NCT03289520) | Clinical Trial Compass
CompletedPhase 3
Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis
United States877 participantsStarted 2003-01-07
Plain-language summary
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
Who can participate
Age range18 Years
SexALL
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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 dialysi…
What they're measuring
1
Fistula thrombosis (patency failure)
Timeframe: 6 weeks
Trial details
NCT IDNCT03289520
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)