Status:
COMPLETED
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 phenomeno...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00684359
Start Date
June 1 2007
End Date
February 1 2010
Last Update
May 31 2010
Active Locations (1)
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1
Ron Waksman, MD, Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010