Aggrenox Prevention of Access Stenosis

Last updated: September 18, 2017
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Completed

Phase

3

Condition

Focal Segmental Glomerulosclerosis

Renal Failure

Kidney Failure (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00067119
VAC GRAFT
U01DK058982
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofenrollment, or current dialysis dependence

  • A new or planned arteriovenous (AV) graft placed in any location for the purpose ofhemodialysis. (Any type of graft material and any configuration of the access isacceptable).

  • The patient is expected to stay at a participating dialysis facility for at least 6months.

  • The patient's physician(s) will allow the patient to participate.

  • Ability to give informed consent.

Exclusion

Exclusion Criteria:

  • Women must not be pregnant, breastfeeding, or plan to be pregnant during the course ofthe study.

  • The presence of ongoing bleeding.

  • The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand'sdisease).

  • Recent bleeding episode requiring transfusion within 12 weeks of entry.

  • The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosisof peptic disease including esophagitis, gastritis, or ulcer or the initiation oftreatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pyloriwithin 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 otherantiplatelet agents other than aspirin.

  • Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hgor 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 orbleeding 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.

Study Design

Total Participants: 649
Study Start date:
January 01, 2003
Estimated Completion Date:
January 31, 2008

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

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