ACTRN12613000354785已完成2 期
Efficacy and Safety Study of the Ivabradine Hydrochloride Tablets versus Atenolol Tablets in Patients With Chronic Stable Angina Pectoris.
Fu Wai Hospital0 个研究点目标入组 336 人开始时间: 2013年4月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Informed Consent
- •2. A history of stable effort angina for greater than or equal to 3 months prior to study
- •3. Evidence of coronary artery disease(CAD) manifested by greater than or equal to 1 of five criteria:
- •(1)Coronary angioplasty greater than or equal to 6 months or bypass surgery greater than or equal to 6 months before entry
- •(2)Coronary angiogram showing greater than or equal to 1 diameter stenosis greater than or equal to 50%,or scintigraphic/echocardiographic evidence of exercise-induced reversible myocardial ischaemia
- •(3) coronary disease(including myocardial infarction) greater than or equal to 3 months before study entry
- •4. LVEF greater than or equal to 50%
- •5. Ischemic ECG changes:1 mm horizontal or downsloping ST-segment depression (measured 0.08s after the J-point on greater than or equal to 3 consecutive complexes) between 3 and 12 min of initiation
- •6. Positive ETT should be manifested
排除标准
- •1. Significant heart disease other than CAD
- •2. Coronary angioplasty<6 months or bypass surgery <6 months
- •3. Myocardial infarction/unstable angina within 3 months
- •4. Known high-grade left main CAD
- •5. Congestive heart failure stage III/IV NYHA
- •6. Resting HR<60bpm
- •7. Arhythmia:e.g,atrial fibrillation/flutter or indwelling pacemaker, 2 degrees and 3 degrees atrioventricular block
- •8. Inability to perform ETT
- •9. Symptomatic hypotension or uncontrolled hypertension [resting systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg]
- •10. FBG greater than or equal to 11.1 mmol/L,or fasting GLU greater than or equal to 13.6 mmol/L
- •11. Anemia(Male:hemoglobin less than or equal to120 g/L;Female:hemoglobin less than or equal to110 g/L)
- •12. Cancer
- •14. Drug or Alcohol abuse
- •15. Psychosis
- •16. Recent treatment with amiodarone (<3 months) or bepridil (<7 days)
- •17. ALT>2 times normal value
- •18. Serum creatinine>180 mmol/L
- •19. Allergic to test drugs
- •20. Pregnancy or breastfeeding
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