The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 inhibit the clotting of platelets in the vessels of patients with PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that have the ability to adhere to each other to form clots.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Boehringer Ingelheim
• Treatments: Aspirin; Dipyridamole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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