Vascular Access Clinical Trials Data Coordinating Center

This study has been completed.
Sponsor:
Collaborators:
The Cleveland Clinic
Boston University
Duke University
University of Iowa
Maine Medical Center
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
Washington University School of Medicine
Baystate Medical Center
Vanderbilt University
CAMC Health System
Emory University
St. Louis University
Tyler Nephrology Associates
Vascular Surgery Associates LLC
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00067119
First received: August 11, 2003
Last updated: March 2, 2010
Last verified: March 2010

August 11, 2003
March 2, 2010
January 2003
January 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00067119 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vascular Access Clinical Trials Data Coordinating Center
1) Clopidogrel Prevention of Early AV Fistula Thrombosis (IND 64169) 2) Aggrenox Prevention of Access Stenosis (IND 64,202)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Kidney Failure
  • Drug: Aggrenox
  • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1284
February 2008
January 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067119
VACTDC (completed)
Yes
Catherine Meyers, MD, Project Officer, NIH/NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Cleveland Clinic
  • Boston University
  • Duke University
  • University of Iowa
  • Maine Medical Center
  • University of Texas Southwestern Medical Center
  • University of Alabama at Birmingham
  • Washington University School of Medicine
  • Baystate Medical Center
  • Vanderbilt University
  • CAMC Health System
  • Emory University
  • St. Louis University
  • Tyler Nephrology Associates
  • Vascular Surgery Associates LLC
Study Director: John W Kusek, Ph.D. NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
Study Director: Catherine Meyers, M.D. NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP