Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
NCT ID: NCT00684359
Last Updated: 2010-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2007-06-30
2010-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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MedStar Research Institute/Cardiovascular Research Institute
Locations
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Ron Waksman, MD, Washington Hospital Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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PRACTICE I
Identifier Type: -
Identifier Source: org_study_id