search
Back to results

Aggrenox Prevention of Access Stenosis (GRAFT)

Primary Purpose

Kidney Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aggrenox
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring Graft Failure, Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Iowa
  • Maine Medical Center
  • Boston University Medical Center
  • Washington University
  • Duke University Medical Center
  • Wake Forest University
  • Vanderbilt University
  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aggrenox

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 11, 2003
Last Updated
September 18, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
The Cleveland Clinic, Boston University, Duke University, University of Iowa, MaineHealth, 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
search

1. Study Identification

Unique Protocol Identification Number
NCT00067119
Brief Title
Aggrenox Prevention of Access Stenosis
Acronym
GRAFT
Official Title
Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
January 31, 2008 (Actual)
Study Completion Date
January 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
The Cleveland Clinic, Boston University, Duke University, University of Iowa, MaineHealth, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Graft Failure, Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aggrenox
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aggrenox
Other Intervention Name(s)
Dipyridamole plus aspirin
Intervention Type
Drug
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Kusek, Ph.D.
Organizational Affiliation
NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine Meyers, M.D.
Organizational Affiliation
NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository
IPD Sharing Time Frame
Data were available in December 2011
IPD Sharing URL
https://www.niddkrepository.org/studies/graft/?query=dac
Citations:
PubMed Identifier
16317809
Citation
Dixon BS, Beck GJ, Dember LM, Depner TA, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kaufman JS, Lawson JH, Meyers CM, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial. Clin Trials. 2005;2(5):400-12. doi: 10.1191/1740774505cn110oa.
Results Reference
background
PubMed Identifier
19458364
Citation
Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, Himmelfarb J, Gassman JJ, Greene T, Radeva MK, Davidson IJ, Ikizler TA, Braden GL, Fenves AZ, Kaufman JS, Cotton JR Jr, Martin KJ, McNeil JW, Rahman A, Lawson JH, Whiting JF, Hu B, Meyers CM, Kusek JW, Feldman HI; DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191-201. doi: 10.1056/NEJMoa0805840.
Results Reference
result
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
PubMed Identifier
34298589
Citation
Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
Results Reference
derived
PubMed Identifier
18477783
Citation
Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
Results Reference
derived

Learn more about this trial

Aggrenox Prevention of Access Stenosis

We'll reach out to this number within 24 hrs