Vascular Access Clinical Trials Data Coordinating Center
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 20, 2015 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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
Last updated: March 2, 2010
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