A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Number of Myocardial Ischemia Attacks in 24 Hours
研究概览
简要总结
This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be diagnosed as stable CHD, and must have at least one of these histories:
- •A history of coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery at least 3 months ago
- •Myocardial infarction
- •More than 50 percent (%) stenosis detected by angiography
- •Exercise Tolerance Testing (ETT) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
- •Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply
排除标准
- •Coronary syndrome or considering acute coronary syndrome (ACS)
- •Left main coronary artery disease without revascularization
- •Aortic stenosis
- •Obstructive hypertrophic cardiomyopathy
- •Subjects with hypertension systolic blood pressure (SBP) greater than (>) 170 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg) or hypotension (SBP less than [<] 90 mmHg or DBP<60 mmHg)
- •Diagnosis as postural hypotension before
- •Congestive heart failure (New York Heart Association [NYHA] class III - IV
- •Ejection fraction (EF)<40% by Echocardiography
- •Arrhythmias requiring active treatment
- •Gastro-intestinal ulcer
- •Concomitant medication such as Sulphonyl urea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Standard treatment plus nicorandil
The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [(ACEIs] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators).
干预措施: Nicorandil (Drug)
Standard treatment plus nicorandil
The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [(ACEIs] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators).
干预措施: Standard Treatment (Drug)
Standard treatment
干预措施: Standard Treatment (Drug)
结局指标
主要结局
Number of Myocardial Ischemia Attacks in 24 Hours
时间窗: At Week 12
Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (\>=) 0.1 millivolts (mV), and lasted for \>= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.
次要结局
- Change From Baseline in Total Myocardial Ischemic Burden at Week 12(Baseline, Week 12)
- Heart Rate Variability (HRV) Rate: Time Domain(At Week 12)
- Number of Arrhythmia Occurred Within 24 Hours(At Week 12)
- Change From Baseline in Maximum ST-depression at Week 12(Baseline, Week 12)
- Number of Subjects Experienced Angina Attack(Baseline up to 12 Weeks)
- Number of Nitroglycerin Tablets Consumed in a Week(At Week 12)
- Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation(From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ))
- Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test(At Week 12)
- Frequency of Angina Attack(At Week 12)
- Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin(At Week 12)
- Change From Baseline in Longest Duration of ST Segment Depression at Week 12(Baseline, Week 12)
- Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour(At Week 12)
- ECG QT Dispersion(At Week 12)
- Walk Distance in Six Minute Walk (6-MWT) Test at Week 12(At Week 12)
- Number of Subjects Who Showed Compliance to Nicorandil(Baseline up to 12 Weeks)