Dialysis Access Consortium (DAC): Clopidogrel Prevention of Early Arteriovenous Fistula Thrombosis
Principle Investigator:
Bradley S. Dixon, M.D.
Study ends:
7/01/2007
Purpose:
To determine whether treatment with the antiplatelet medication clopidigrel (Plavix) started immediately after creation of a new arteriovenous fistula will prevent clotting of the fistula and lead to more arteriovenous fistulae becoming usable for dialysis.
Overview:
An arteriovenous fistula is a surgically created connection of vein to artery typically in the arm that allows needles to be easily inserted to withdraw blood for hemodialysis. An arteriovenous fistula is the optimal vascular access for hemodialysis but some fistulae fail after surgery due to clotting. This multicenter trial will test whether the antiplatelet medication clopidogrel will prevent clotting and lead to more fistulae that are usable for dialysis. Participants will be enrolled prior to fistula surgery. Following creation of the fistula, participants will be randomly assigned to treatment with either clopidogrel 75 mg a day by mouth or a matched placebo starting immediately after the surgery and continuing for 6 weeks. Neither the study doctor nor the participant will know which medication they are taking. At the end of 6 weeks the fistula will be examined to determine whether it is still open. Participants will also be followed to determine whether the fistula is ultimately usable for hemodialysis.
Eligibility:
Patients 18 years of age or older with chronic renal failure who are on chronic hemodialysis or anticipated to begin chronic hemodialysis within 6 months are eligible to participate. Patients who already require treatment with clopidogrel, aspirin or warfarin or who have a serious bleeding disorder that precludes use of clopidogrel are not eligible for enrollment.
Sponsor:
National Institutes of Health / National Institutes of Diabetes and Digestive and Kidney Diseases.
Contact Info:
For further information please contact Mr. Bradley Franzwa at 319-353-6689.
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