Aggrenox Prevention of Access Stenosis

NCT00067119 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: VAC GRAFTU01DK058982
• Study Type: interventional
• Target: 649
• Locations: 1 country
• Sites: 9

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.

Conditions

Kidney Failure

Keywords

Graft Failure; Access Blood Flow Monitoring; Clinical Trial Vascular Access; Fistula Failure; Hemodialysis; Vascular Access

Study Arms (2)

Aggrenox

EXPERIMENTAL

Drug: Aggrenox

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aggrenox DRUG

Also known as: Dipyridamole plus aspirin

Aggrenox

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (5)

• 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.

  PMID: 16317809 BACKGROUND

• 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.

  PMID: 19458364 RESULT

• 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.

  PMID: 35224730 DERIVED

• 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.

  PMID: 34298589 DERIVED

• 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.

  PMID: 18477783 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Aspirin, Dipyridamole Drug Combination; Dipyridamole; Aspirin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2003
• First Posted: August 13, 2003
• Study Start: January 1, 2003
• Primary Completion: January 31, 2008
• Study Completion: January 31, 2008
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data were available in December 2011

Locations

US (9)