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Vascular Access Clinical Trials Data Coordinating Center

Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure

Intervention: Aggrenox (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
John W Kusek, Ph.D., Study Director, Affiliation: NIDDK - Telephone: 301-594-7717; Email: kusekj@ep.niddk.nih.gov
Catherine Meyers, M.D., Study Director, Affiliation: NIDDK - Telephone: 301-451-4901; Email: meyersc@extra.niddk.nih.gov

Summary

Fistula Study: The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae.

Graft Study: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts.

Clinical Details

Official title: 1) Clopidogrel Prevention of Early AV Fistula Thrombosis (IND 64169) 2) Aggrenox Prevention of Access Stenosis (IND 64,202)

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Fistula Study Protocol

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

- Planned creation of native upper extremity AV fistula

- The patient is not on aspirin, or the patient is on aspirin but has not had a

myocardial infarction or a cerebrovascular accident within the past 12 months.

- 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.

- A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or

nonsteroidal anti-inflammatory drugs dudring the six week study drug administration period. Use of heparin during dialysis is allowed.

- Required use of oral or intravenous glucocorticoids at a dose greater than the

equvalent of prednisone 15 mg per day during the six week study drug administration period.

- Current unstable angina.

- Required use of clopidogrel.

- Known hypersensitivity to clopidogrel.

- Medical considerations making anti-platelet therapy dangerous.

- Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm

Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.

- 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.

Graft Study Protocol

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 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.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of Iowa, Iowa City, Iowa 52242, United States

Maine Medical Center, Portland, Maine 04102, United States

Boston University Medical Center, Boston, Massachusetts 02118, United States

Washington University, St. Louis, Missouri 63110, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Wake Forest University, Winston-Salem, North Carolina 27157, United States

Vanderbilt University, Nashville, Tennessee 37232, United States

University of Texas Southwestern, Dallas, Texas 75390, United States

Additional Information

Related publications:

Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22.

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.

Starting date: January 2003
Ending date: February 2008
Last updated: April 10, 2008

Page last updated: June 20, 2008

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