Trial Information

Summary: Effect Of Clopidogrel Versus Placebo, On A Background Of Standard Care Including Aspirin, In Maintaining The Patency of Lower Limb Arteries After Angioplasty

Pain In Your Legs When Walking? It may Be Your Circulation. Exciting New Research Study To Help Your Leg Circulation.

We are conducting a clinical research study to evaluate the effectiveness and safety of a drug (clopidogrel) versus an inactive compound (placebo) in keeping leg arteries open after a successful angioplasty procedure has been performed. Everyone in the study will receive aspirin and other standard treatments deemed appropriate. Clopidogrel is a prescription pill that has been approved by the Food and Drug Administration and has been shown to prevent heart attacks and strokes in patients with leg circulation problems. Clopidogrel has not been approved by the Food and Drug Administration for patients who have undergone angioplasty in their legs.

You may qualify for participation in this study if you have circulation problems in your legs causing pain, cramping, aching, heaviness, tiredness, discomfort, or numbness in the legs that is caused by walking and relieved by stopping walking.

Approximately 2000 subjects at about 100 centers in the United States who have leg circulation problems will be included in this research program. Approximately 12 patients will be enrolled at Mount Sinai Medical Center.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1. Male or female of any race and age >40 years.
2. Has been diagnosed with Peripheral Arterial Disease
3. Has undergone successful Percutaneous Transluminal Angioplasty of the leg

1. History of bleeding problems
2. Heart attack or stroke within the past 3 months
3. Major surgery within the prior 6 weeks.
4. Allergy or intolerance or contraindications to the use of aspirin
5. Low platelet count
6. Uncontrolled high blood pressure
7. Severe kidney or liver disease
8. Pregnant women and women of child-bearing potential who are nursing or who are not using an adequate method of birth control.
9. Receiving chronic anticoagulation therapy

If you would like to learn more about participating in this study, please send an e-mail message using the form below.