Angina Pectoris Clinical Trial
Official title:
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
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.
1. 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)。
2. 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.
3. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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