Aggrenox Prevention of Access Stenosis

Kidney Failure Clinical Trial

— GRAFT  

Official title:

Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067119
• Other study ID #: VAC GRAFT
• Secondary ID: U01DK058982
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2003
• Last updated: September 18, 2017
• Start date: January 1, 2003
• Est. completion date: January 31, 2008

Study information

• Verified date: September 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: January 31, 2008
• Est. primary completion date: January 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Aggrenox

• Placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University Medical Center	Boston	Massachusetts
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University	Nashville	Tennessee
United States	Maine Medical Center	Portland	Maine
United States	Washington University	Saint Louis	Missouri
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (16)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Baystate Medical Center, Boston University, CAMC Health System, Duke University, Emory University, Maine Medical Center, St. Louis University, The Cleveland Clinic, Tyler Nephrology Associates, University of Alabama at Birmingham, University of Iowa, University of Texas Southwestern Medical Center, Vanderbilt University, Vascular Surgery Associates LLC, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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, — View Citation