Status:
TERMINATED
The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
This research study will evaluate the effects of aspirin and dipyridamole alone and in combination on the blood flow in the vessels of the legs. We will examine how these medications are able to inhib...
Detailed Description
Dipyridamole has been reformulated to guarantee systemic bioavailability and steady state levels compatible with inhibition of platelet aggregation ex vivo (1). This newly formulated dipyridamole has ...
Eligibility Criteria
Inclusion
- Age between 18 - 79
- Women of child bearing potential using a medically acceptable method of birth control (oral/transdermal/vaginal hormonal contraception, depo-provera injection, IUD, condom with spermicide, progestin implant, tubal ligation, oophorectomy, TAH) or abstinence.
- Capacity for giving written consent
- Diagnosis of PAD by:
- previous angiogram (\>0.5 stenosis of a peripheral artery)
- ankle-brachial index (ABI) of systolic pressure \<0.80
- previous peripheral revascularization
- Smokers who smoke \< 10 cigarettes / day
Exclusion
- Female subjects who are pregnant or nursing a child.
- Prior bleeding event related to drug therapy
- History of gastrointestinal ulceration
- History of known dipyridamole and/or aspirin allergy or intolerance
- History of coagulation, bleeding or blood disorders.
- Recent history of myocardial infarction or stroke in the previous 6 months
- Resting blood pressure of \<110mmHg systolic or \<60mmHg diastolic or of \>165mmHg systolic or \>95mmHg diastolic
- Patients with active infection as documented by abnormal laboratory tests at screen
- Concomitant serious illness, such as cancer, as per the principal investigator's discretion
- Current use of steroids for a chronic disease process
- Presence of ischemic leg ulcers
- History of contact allergies to the metal leads of the NIRS
- History of drug or alcohol abuse within the last 6 months.
- Subject who has received an experimental drug and/or used an experimental device within 30 days of screening.
- Subject who has donated ≥ one pint of blood within 8 weeks prior to screen.
- Use of aspirin for 2 weeks prior to the study
- Use of any other NSAID or COX-inhibitor for one week prior to the start of the study
- Use of any antioxidant vitamin for 2 weeks prior to the start of the study
- Use of plavix, pletal or trental for one week prior to the start of the study
- Use of acetaminophen for one week prior to each study visit
- Use of alcohol, caffeine or high fat foods for 24 hours prior to each study visit
- Has smoked any cigarettes for 24 hours prior to each study visit
- Platelet aggregation blood test less than 60 percent at Visit 1
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00906035
Start Date
September 1 2002
End Date
April 1 2010
Last Update
September 5 2017
Active Locations (3)
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1
Presbyterian Hospital, 51 N. 39th St.
Philadelphia, Pennsylvania, United States, 19104
2
Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421
Philadelphia, Pennsylvania, United States, 19104
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104