Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I

Completed

Conditions studied: Coronary Disease

In brief

Single center randomized parallel group study to determine if: 1. there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon. 2. the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.

Key facts

Study ID

NCT00684359

Run by

Medstar Health Research Institute

People needed

30

Starts

2007-06-01

Expected to finish

2010-02-01

Last updated by the study team

2010-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients, male or female, > 18 years of age,
• Patients who are scheduled for an elective PCI with a drug eluting stent
• Patients willing to return for all required follow up visits.
• Patients live/work within a 60 mile radius of the Washington Hospital Center.

You may not qualify if…

• Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
• Unprotected left main coronary disease with >50% stenosis;
• Patients with renal failure requiring dialysis;
• Patients with a documented ejection fraction < 30 percent at the time of subsequent PCI;
• Patient with a life expectancy less than 12 months or malignancy.
• Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be medically managed;
• Planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of PCI;
• Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
• Patients with known history of bleeding diathesis;
• Prothrombin time >1.5 times control; coumadin therapy
• Platelet count <100 000/mm3;
• Hematocrit <25%;
• Creatinine >4.0 mg/dL;
• Thienopyridine use within 5 days of enrollment
• Glycoprotein (GP) IIb/IIIa use within 8 hours of enrollment or any indication were the operator will require GP IIb/IIIa inhibitor use during the hospitalization.

Where it is running

• Ron Waksman, MD, Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.