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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000354785

Enrollment

336

Registered

2013-04-03

Start date

2009-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

1. To evaluate the effectiveness,safety and tolerance of Ivabradine Hydrochloride in patients with chronic stable angina 2. To demonstrate that Ivabradine Hydrochloride non-inferiority to Atenolol with chronic stable angina 3. Chinese patinets with chronic stable angina can have more choices of antianginal drugs,especially to that have an allergy or intolerance to beta receptor blockers.

Interventions

Patients with chronic stable angina receive Ivabradine Hydrochloride tablets 5 mg twice a day for 4 weeks,and then if resting heart rate is greater than 80bpm,participants take 7.5mg twice a day for 8 weeks; if resting heart rate is less than or equal to 80bpm,participants take 5mg twice a day for 8 weeks. The subjects had only one drug number.Investigators should keep an account of the actual dose,and record the grant and recovery of drugs.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results