Aggrenox Prevention of Access Stenosis

Phase 3

Completed

• Conditions: Kidney Failure
• Interventions: Drug: Aggrenox; Drug: Placebo

• Registration Number: NCT00067119
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01-01
• Study First Submitted: 2003-08-11
• Study First Submitted QC: 2003-08-12
• Study First Posted: 2003-08-13
• Primary Completion: 2008-01-31
• Study Completion: 2008-01-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggrenox	Aggrenox	-
Placebo	Placebo	-

Trial Locations

Locations (9)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States