Fistula Study: The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae.

Graft Study: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts.

Condition	Treatment or Intervention	Phase
Kidney Failure	Drug: Aggrenox  Drug: Clopidogrel	Phase III

Further Study Details: 

Expected Total Enrollment:  1284

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 dudring 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 equvalent 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.

Graft 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
• A new or planned AV graft placed in any location for the purpose of hemodialysis. (Any type of graft material and any configuration of the access is acceptable).
• 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.
• Known allergy or adverse reaction to Aggrenox or any of its study components (dipyridamole and aspirin).
• Required use of warfarin, dipyridamole, non-steroidal antiinflammatory drugs or other antiplatelet agents other than aspirin.
• Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg.
• 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.

Gerald J Beck, Ph.D.      216-444-9927    gbeck@bio.ri.ccf.org
Harold I Feldman, M.D.      215-898-0901    hfeldman@cceb.med.upenn.edu

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Maine
      Maine Medical Center, Portland,  Maine,  04102,  United States; Recruiting
Massachusetts
      Boston University Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Texas
      University of Texas Southwestern, Dallas,  Texas,  75390,  United States; Recruiting

Study chairs or principal investigators

John W Kusek, Ph.D.,  Study Director,  NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov   
Catherine Meyers, M.D.,  Study Director,  NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov   

Study ID Numbers:  VACTDC
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  August 11, 2003
ClinicalTrials.gov Identifier:  NCT00067119
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08