NCT01185015撤回4 期
A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Time to 1 mm ST-depression
研究概览
简要总结
The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should be 18~70 years old, male or female
- •Subjects should have a history of coronary revascularization at least 6 months ago
- •Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
- •Subjects should be relieved from anginal attacks with short-acting NTG
- •Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
- •Subjects should have an ability to give written informed consent
排除标准
- •Unstable angina
- •Left main coronary artery disease
- •Aortic stenosis
- •Obstructive hypertrophic cardiomyopathy
- •Subjects with hypertension (SBP>170 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg)
- •Postural hypotension (drop in systolic blood pressure >20% after 2 minute standing),
- •Congestive heart failure (NYHA class III - IV)
- •Ejection fraction (EF)<45% by Echocardiography
- •Peripheral arterial obstructive disease or other diseases limiting exercise testing
- •Arrhythmias requiring active treatment
- •Gastro-intestinal ulcer
- •Liver dysfunction (defined as ALT or bilirubin>1.5×upper limit of normal value)
- •Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
- •Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
- •Known intolerance to nitrates
- •Known allergic to nicotinic acid
- •Pregnant or lactating women
- •Any other contraindications mentioned in the SPC
- •Participation in another clinical study within the last 3 months
- •Legal incapacity or limited legal capacity
- •Any other subjects assessed by the investigator as being unsuitable for the present study
结局指标
主要结局
Time to 1 mm ST-depression
时间窗: until day 28
It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads
次要结局
- Exercise tolerance test parameters(until day 28)
- Consumption of nitroglycerine (NTG).(until day 28)
- Adverse events(until day 28)
- Compliance(until day 28)
- Number of angina attacks per week(until day 28)
研究者
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