NCT02284048Unknown4 期
Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Second Xiangya Hospital of Central South University0 个研究点目标入组 140 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 主要终点
- adenosine-induced coronary flow reserve (CFR)
研究概览
简要总结
This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA
详细描述
Considering the reduced CFR and increased platelet aggregability in patients with MVA, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with MVA.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 18-80 years
- •A diagnosis of stable primary MVA based on the presence of
- •a history of typical effort angina,
- •exercise-induced ST-segment depression>1 mm,
- •normal or near-normal (coronary artery stenosis<50%) coronary angiography,
- •absence vasospastic angina
- •a coronary flow reserve (CFR) <2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (CBF) response to adenosine at transthoracic Doppler echocardiography
- •suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of >1 episode per week of angina
排除标准
- •ubjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •concomitance with any of the cardiac condition below
- •significant （>50%）coronary plaque disease
- •coronary artery spasm at angiography or other evidence of vasospastic angina
- •valvular or other structural heart disease
- •uncontrolled hypertension
- •abnormal echocardiographic examination including left ventricular hypertrophy
- •no previous consumption of the ticagrelor
- •no apparent contraindications to ticagrelor administration.
- •History of Intracranial Hemorrhage
- •Active Bleeding
- •Severe Hepatic Impairment: AST and ALT are greater than 3 times of the upper limit. Bilirubin is greater than the upper limit.
- •hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product
- •severe COPD or asthma
研究组 & 干预措施
control
Placebo Comparator
nitrate,beta blocker
干预措施: ticagrelor (Drug)
ticagrelor
Active Comparator
ticagrelor 90mg qd
干预措施: ticagrelor (Drug)
结局指标
主要结局
adenosine-induced coronary flow reserve (CFR)
时间窗: 2 months
次要结局
未报告次要终点
研究者
Daoquan Peng
Professor
Second Xiangya Hospital of Central South University
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