District of Columbia
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
- 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.
- 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
- Patient with a life expectancy less than 12 months or malignancy.
- Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be
- 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.