NCT00684359已完成不适用
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon
研究概览
简要总结
Single center randomized parallel group study to determine if:
- there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
- 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.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon
时间窗: Up to 12 months
次要结局
- To determine what 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.(up to 12 months)
研究者
研究点 (1)
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