Evaluation of the anti-anginal efficacy and safety of ivabradine used in combination with an anti-anginal monotherapy in patients with stable effort angina pectoris

Evaluation of the anti-anginal efficacy and safety of ivabradine used in combination with an anti-anginal monotherapy in patients with stable effort angina pectoris. A 6-week, randomised, double-blind controlled, parallel-group, international, multicentre study.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12001878

Enrollment

Unknown

Registered

2012-01-09

Start date

2008-01-10

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Stable effort angina pectoris

Interventions

Ivabradine:Oral ivabradine tablets twice daily 5mg or 7,5mg (target dose: 7.5mg following dose titration based on HR and clinical criteria).

Placebo:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male, sterile or post-menopausal female patients, aged >=18 years old, with a history of typical effort angina pectoris, with clinical stability, no angina at rest and no angina of class IV (according to the CCS Classification). Patients could be either untreated for their angina or treated with an authorised anti-anginal monotherapy (but not a beta-blocker, diltiazem, verapamil, or bepridil) and this treatment was to be stable for at least 1 month prior selection. All patients were to be symptomatic with at least 4 angina attacks/week before the inclusion visit. Patients enrolled in the ETT sub-study were required to have a positive ETT for inclusion in the sub-study (where positivity was confirmed by the central reading centre).

Exclusion criteria

Exclusion criteria: 1. Symptomatic bradycardia on (pre-) selection or HR 5 cm, known left ventricular aneurysm; 9. Congestive heart failure stage III or IV (classification of the NYHA or uncontrolled heart failure); 10. Cardiogenic shock; 11. Severe hypotension (SBP < 90 mmHg) or uncontrolled hypertension: 12. No sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation present at the time of (pre-) selection, flutter; 13. Pacemaker or implanted cardioverter-defibrillator (ICD); 14. Patients previously treated with a combination of anti-anginal treatments (except if the combination involved short acting nitrates); 15. Contra-indication to ivabradine.

Design outcomes

Primary

Measure	Time frame
Relative change in the mean number of angina attack;Relative change in the mean consumption of short acting nitrates per week over a 6-week treatment;	—

Secondary

Measure	Time frame
Heart rate (HR, bpm);Canadian cardiovascular society (CCS) class;	—

Countries

Vietnam

Contacts

Public ContactProf. GAO Run Lin

gaorunlin@263.net+86 10 68331622

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026