Efficacy and Safety Study of the Ivabradine Hydrochloride Tablets versus Atenolol Tablets in Patients With Chronic Stable Angina Pectoris.

Phase 2

Completed

• Conditions: Coronary heart disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12613000354785
• Lead Sponsor: Fu Wai Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

1. Informed Consent
2. A history of stable effort angina for greater than or equal to 3 months prior to study
entry
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

Exclusion Criteria

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
13. Aids
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative change in the Total Exercise Duration during exercise tolerance tests (ETT)[Baseline, and at 12 weeks after intervention commencement]