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
  Purpose

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 Intervention Phase
Kidney Failure
Drug: Aggrenox
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 1) Clopidogrel Prevention of Early AV Fistula Thrombosis (IND 64169) 2) Aggrenox Prevention of Access Stenosis (IND 64,202)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 1284
Study Start Date: January 2003
Study Completion Date: February 2008
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067119

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and 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
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Meyers, MD, Project Officer, NIH/NIDDK
ClinicalTrials.gov Identifier: NCT00067119     History of Changes
Other Study ID Numbers: VACTDC (completed)
Study First Received: August 11, 2003
Last Updated: March 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Graft Failure
Access Blood Flow Monitoring
Clinical Trial Vascular Access
Fistula Failure
Hemodialysis
Vascular Access

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Clopidogrel
Aspirin, dipyridamole drug combination
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014