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Aggrenox Prevention of Access Stenosis (GRAFT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067119
First Posted: August 13, 2003
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 11, 2003
August 13, 2003
September 19, 2017
January 1, 2003
January 31, 2008   (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
 
Aggrenox Prevention of Access Stenosis
Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Failure
  • Drug: Aggrenox
    Other Name: Dipyridamole plus aspirin
  • Drug: Placebo
  • Experimental: Aggrenox
    Intervention: Drug: Aggrenox
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
649
January 31, 2008
January 31, 2008   (Final data collection date for primary outcome measure)

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 arteriovenous (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00067119
VAC GRAFT
U01DK058982 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Data will be available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository
Time Frame: Data were available in December 2011
URL: https://www.niddkrepository.org/studies/graft/?query=dac
National Institute of Diabetes and Digestive and Kidney Diseases (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)
September 2017

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