NCT02623569Unknown2 期
Evaluation of the Anti-anginal Efficacy and Safety of Ivabradine Used in Patients With Stable Effort Angina Pectoris. A 12 Weeks Randomised, Double-blind Controlled, Parallel-group, Multicentre Study
Xintong Pharmacy Company3 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 336
- 试验地点
- 3
- 主要终点
- The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT)
研究概览
简要总结
Arms Assigned Interventions
Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR>60times/min or negative ETT and HR>80times/min of subjects.
Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate>60times/min or negative ETT and HR >80times/min of subjects.
详细描述
- Washout period：Chronic angina patients stop using medicine that affect heart rate. The patients undergoes ETT after 2-7 days and positive ETT into the treatment period(If not take similar medicine, patients can be carried out ETT directly)。
- Treatment period：Patients carried out ETT after therapy with Ivabradine(5mg,bid)/ Atenolol(12.5mg,bid) for 4 weeks.The dose adjust base on test result and heart rate, Ivabradine(5mg,bid)/Atenolol(12.5mg,bid) or Ivabradine(7.5mg,bid)/ Atenolol(25mg,bid) for 8 weeks and carried out ETT.
- security period：After the treatment period, all patients to take Atenolol 12.5mg/ 25mg bid 1 week.
If heart rate are low 50 times/min after taking Ivabradine 5mg/ Atenolol 12.5mg, subjects should withdrawal and dropped out study. If subjects heart rate are low 50 times/min after taking Ivabradine 7.5mg/ Atenolol 25mg, subjects should change the dose to Ivabradine 5mg/ Atenolol 12.5mg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged 18 to 75 years
- •Clearly understand the study and participate in it voluntarily; the informed consent should be signed in person or by legal guardian.
- •Chronic Stable Angina was confirmed by clinic over 3 months.
- •Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:
- •Patients who have a history of myocardial infarction over 3 months.
- •Patients who have received coronary intervention or CABG（Coronary Artery Bypass Grafting） over 6 months.
- •Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph.
- •Ischemic electrocardiogram changes：ST-segment depression ≥ 1.0 mm compared with P-R or elevate≥1.0 mm during exercise ECG Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
- •ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %.
- •Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening.
排除标准
- •Clinically significant Valvular disease, congenital heart disease, pulmonary hypertension, cerebral apoplexy, dissecting aneurysm, hypertrophic cardiomyopathy, acute myocarditis/cp.
- •Patients with myocardial infarction within the preceding 3 months
- •Patients have received Coronary angioplasty or CABG within the preceding 6 months.
- •Patients who have severity vessels disease with left main coronary artery but have no valid treatment.
- •Patients with congestive heart failure(New York Heart Association class III or IV)or acute pulmonary edema.
- •Patients whose rest heart rate< 60 bpm.
- •Patients with nonrespiratory sinus arrhythmia or arrhythmia(e.g.,AVB(auriculo-ventricular block)ⅡⅢ,atrial fibrillation,atrial flutter,SSS(sick sinus syndrome)) or implantable cardiac defibrillator (ICD).
- •Patient with any conditions that interfered the performance of exercise tolerance test or a history of an abnormal exercise response limited by electrocardiograph (ECG) changes.
- •Patient with uncontrolled hypertension (seated systolic blood pressure (SBP）≥180 mmHg or diastolic blood pressure (DBP) ≥100 mmHg); SBP<90 mmHg and/or DBP<60 mmHg
- •Diabetic with uncontrolled blood glucose(FBG≥11.1 mmol/L and/or RBG≥13.6 mmol/L）
- •Patients with anemia(male:Hb≤120 g/L；female：Hb≤110 g/L)
- •Patients complicated with systemic diseases included thyroid dysfunction、glaucoma、cataract，neurological、mental、psychological disease and any other disease that influence the judgment.
- •Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.).
- •Patients with mental or legal disorder.
- •Patients who were suspected addicted into alcohol or drug abuse or with severe complications that would make the condition more complicated assessed by the investigator.
- •People have liver or renal dysfunction (ALT≥2×ULN、AST≥2×ULN、eGFR≤60ml/min/1.73m2）
- •Patients who should use unapproved drug during the study.
- •Patients who accepted amiodarone(in recent 3 months)and/or benzetimide、βblockers（in recent 7 days)、
- •Patients with history of allergy or suspected allergic to the drug（e.g.，Hydrochloric ivabradine,atenolol, βblockers）or lactose.
- •Woman who disagree with contraception during treatment period ，with pregnancy, lactation or positive result of pregnancy test.
- •Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators.
- •Patients who is participating in other trials or has been participated in other trials in recent 3 months
- •Patients who were unable to participate in the study as judged by investigator.
研究组 & 干预措施
Ivabradine
Experimental
Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR（heard rate）>60times/min or negative ETT and HR（heard rate）>80times/min of subjects.
干预措施: Ivabradine (Drug)
Atenolol
Active Comparator
Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and HR（heard rate）>60times/min or negative ETT and HR （heard rate）>80times/min of subjects.
干预措施: Atenolol (Drug)
结局指标
主要结局
The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT)
时间窗: Baseline and end of treatment (Week 12) .
次要结局
- Time to angina in exercise tolerance test.(12 weeks)
- Time to 1 mm ST-segment depression in exercise tolerance test(12 weeks)
- Number of angina attacks in exercise tolerance test per week(12 weeks)
- Number of sublingual nitroglycerin consumption per week(12 weeks)
研究者
研究点 (3)
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