A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Index of microcirculatory resistance using 0.014-in coronary pressure wire
研究概览
简要总结
Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes, a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary syndrome patients on ASA background, have demonstrated superiority of ticagrelor over clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation. Several experimental and clinical studies support the hypothesis that adenosine could reduce cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there are no available data on coronary circulation effects after chronic treatment of ticagrelor in patients with ACS who have altered resting coronary blood flow dynamics due to advanced coronary artery disease.
详细描述
This study is a prospective, randomized, open-label, active controlled study with two parallel study groups.
For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged 20-85 years
- All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.
- Be able to understand and comply with the requirements of the study, as judged by the investigator.
To investigate the effects of ticagrelor on coronary microcirculation, IMR will be measured twice, 6 months apart in the same lesion, compared with clopidogrel.
The IMR is defined as simultaneously measured distal coronary pressure divided by the inverse of the thermodilution-derived hyperaemic mean transit time (Tmn), or more simply, distal coronary pressure multiplied by the Tmn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.
- •Be able to understand and comply with the requirements of the study, as judged by the investigator.
排除标准
- •History of intracranial bleeding
- •Severe hepatic impairment
- •Active pathologic bleeding
- •Hypersensitivity to ticagrelor or any of the excipients
- •Liver cirrhosis greater than or equal to Child class B
- •Decreased serum platelet level (≤ 100,000/uL)
- •Life expectancy ≤ 1 year
- •Need for chronic oral anticoagulant therapy
- •Patients with known bleeding diathesis or coagulation disorder
- •History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days.
- •Ischemic stroke within the previous 14 days
- •Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- •Concern for inability of the patient to comply with study procedures and/or follow up
- •Unable to give informed consent.
研究组 & 干预措施
Ticagrelor
Ticagrelor 90mg, twice a day
干预措施: Ticagrelor (Drug)
Clopidogrel
Clopidogrel 75mg, once a day
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Index of microcirculatory resistance using 0.014-in coronary pressure wire
时间窗: 6 months
次要结局
- Fractional flow reserve using 0.014-in coronary pressure wire(6 months)
- Coronary flow reserve using 0.014-in coronary pressure wire(6 months)
研究者
Kyungil Park
Assistant professor
Dong-A University