Prospective Pilot Study- Does Mean Platelet Volume Change With Clopidogrel in Patients With Stable Angina Undergoing Percutaneous Coronary Intervention?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Change in MPV (∆MPV) with clopidogrel in stable angina patients undergoing PCI.
研究概览
简要总结
Platelets play a major role in thrombus formation and platelet size, measured by Mean Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with Myocardial Infarction (MI) and is an independent predictor of adverse events in patients with ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina is limited.
Aspirin and clopidogrel are antiplatelet agents administered routinely to patients undergoing PCI and are required for stent patency. MPV is not known to be affected by low dose Aspirin. Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude of this reduction in MPV is unclear, especially in patients with stable angina undergoing PCI. An inverse correlation also exists between MPV and platelet count .
The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel administration in patients with stable angina undergoing PCI.
详细描述
This is a prospective, observational study. The investigators aim to conduct this pilot study to assess if there is a change in MPV (∆ MPV) after routine clopidogrel in patients with stable angina undergoing PCI.
Reduced responsiveness to clopidogrel (otherwise known as clopidogrel resistance) is well documented. Clopidogrel resistance can result in adverse long term effects including stent thrombosis and mortality. Diagnosis of clopidogrel resistance requires special analyzers and reagents . There are potential cost factors involved with the analyzers and reagents used for testing resistance. There are no known clinical or biochemical markers of clopidogrel resistance.
If our pilot study results demonstrate that MPV does change (∆MPV) after clopidogrel, then a prospective trial can be conducted in future to correlate ∆MPV with clopidogrel resistance measured by analyzer tests. This could establish ∆MPV as a potential cheap, effective biochemical marker for clopidogrel resistance.
If the investigators are successful in demonstrating a change in MPV with clopidogrel, our pilot study will facilitate conducting future larger studies to demonstrate correlation between ∆MPV and clopidogrel resistance. This could establish ∆MPV as a potential cheap, effective biochemical marker for clopidogrel resistance with resultant benefit to subjects and the institution.
All clopidogrel naive patients with stable angina symptoms who are electively listed for coronary angiography and PCI at Peter Munk Cardiac Centre (PMCC), Toronto General Hospital (TGH), will be included in this pilot study. This pilot study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and University Health Network (UHN) policy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Able to attend for follow up blood tests
- •Able to provide written informed consent
排除标准
- •<18 years of age
- •Unable to attend for follow up blood tests on days 1, 7 and 30
- •Already on clopidogrel at least 1 day prior to presenting for angiography/PCI
- •Those who undergo only diagnostic angiography
- •History of Myocardial Infarction (MI) in last 1 year
- •Anemia (Hb<100)
- •Abnormal (low or high out of range) platelet counts
- •Diabetes Mellitus
- •Known liver disease
- •Known severe renal impairment (eGFR <30ml/min/1.73m2)
- •Known pregnancy
- •On Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or steroids
- •Known connective tissue disease
- •Acute ongoing infections or bleeding
- •On oral anticoagulant treatment in the last 1 week
- •Pro-coagulant blood disorder
- •Known immunosuppressed states
- •Treatment with GpIIb/IIIa inhibitor in the last week prior to presentation
- •Patients involved in other trials
结局指标
主要结局
Change in MPV (∆MPV) with clopidogrel in stable angina patients undergoing PCI.
时间窗: 30 days
次要结局
- Change in Platelet count (∆ platelet count) with clopidogrel in stable angina patients(30 days)
- Correlation between ∆MPV and adverse events (readmission and Myocardial Infarction) at 30 days(30 days)