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

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