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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)
  Purpose
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.

Condition Intervention Phase
Kidney Failure Drug: Aggrenox Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency

Resource links provided by NLM:


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

Enrollment: 649
Actual Study Start Date: January 1, 2003
Study Completion Date: January 31, 2008
Primary Completion Date: January 31, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aggrenox Drug: Aggrenox
Other Name: Dipyridamole plus aspirin
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Saint 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
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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00067119     History of Changes
Other Study ID Numbers: VAC GRAFT
U01DK058982 ( U.S. NIH Grant/Contract )
First Submitted: August 11, 2003
First Posted: August 13, 2003
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Aspirin
Dipyridamole
Aspirin, Dipyridamole Drug Combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Phosphodiesterase Inhibitors
Vasodilator Agents