Aggrenox Prevention of Access Stenosis



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:9/20/2017
Start Date:January 1, 2003
End Date:January 31, 2008

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Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency

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.


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.
We found this trial at
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Dallas, Texas 75390
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Boston, MA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Saint Louis, Missouri 63110
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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