Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with atenolol in patients with stable angina pectoris.A 4-month randomised double-blind parallel-group international multicentre study.

Institut de Recherches Internationales Servier0 个研究点目标入组 750 人开始时间: 2005年9月1日最近更新: 2021年8月2日

适应症

试验速览

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•Patients to be selected will be male or female outpatients between 18 (or the legal age) and 75 years with a history of stable angina pectoris (duration >or= 3 months) with no angina at rest and no angina of class IV of the Canadian Cardiovascular Society classification, treated by atenolol 50 mg o.d. or by any other beta-blocker at equivalent dosage (duration of treatment >or= 3 months) and who still present a positive ETT or symptomatic angina in everyday life. Heart rate (ECG) at rest with atenolol (50 mg o.d.) must be >or= 60 bpm at pre-selection and inclusion. Patients to be included should have three positive exercise tolerance tests (limiting angina pain + ST depression >or= 1 mm within 3 min to 12 min) and stable exercise tolerance test (time to 1 mm ST segment depressions between second selection visit and inclusion visit ETT must be within ± 20% or ±1 min of each other) during the run-in period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Modification of a selection criteria that would prevent the patient of being included.
•- Any clinical deterioration during the run-in period, as demonstrated by a significant increase in the mean number of anginal attacks per week and by a significant increase in the mean nitrates consumption per week (increase by more than 5 in the mean number of angina attacks per week and by more than 50% respectively between SEL1 and M0 visits).
•- HR < 60 bpm measured on ECG at rest.
•- Compliance to atenolol and placebo < 75% or > 130%.
•- Patient having stopped the ETT preceding inclusion before reaching the positivity criteria for one of the reasons listed in appendix 4 as criteria for early interruption of the exercise test.
•- Non stability in ST segment depression.
•- Abnormalities in the laboratory blood tests performed at SEL2 considered to be dangerous for the patient if he/she continued in the study:
•- severe renal failure (serum creatinine > 200 micromoles per litre),
•- severe liver function test abnormalities: ALAT or ASAT > 3 times the upper normal values,
•- electrolyte disorders, particularly kaliema < 3.5 mmol/l or > 5.2 mmol/l,
•- significant anaemia defined as blood haemoglobin lower than 110 grams per litre (in males) or lower than 100 grams per litre (in females).

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