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: 2020年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Fu Wai Hospital