A clinical trial with ivabradine in patients with stable coronary artery disease
- Conditions
- Health Condition 1: null- Stable coronary artery disease without clinical heart failure
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16850
The main inclusion criteria will be:
(1) History of coronary artery disease documented by either (a) a previous myocardial infarction ( > 3 months) or (b) a coronary revascularisation in 2 or more major coronary arteries ( > 3 months) or, in the absence of (a) and (b), (c) the imaging evidence of at least 50% narrowing in one or more major coronary arteries plus either a positive non invasive stress test, or a hospitalisation with a documented clinical diagnosis of unstable angina (within 12 months prior to selection), and
(2) Preserved left ventricular systolic function defined as left ventricular ejection fraction of 41% or higher on a two-dimensional echocardiography or a radionuclide ventriculography or computed tomography angiography or magnetic resonance imaging, and
(3) Sinus rhythm and resting heart rate equal to or higher than 70 bpm on 2 consecutive resting standard 12-lead ECGs performed at least 5 minutes apart, at selection and inclusion visits (if one of the 2 HR measurements is 68 or 69 bpm at the inclusion visit, it will be allowed to include the patient, provided that the mean of both HR measurements at the visit is > 70 bpm), and
(4) Informed consent obtained, and
(5) Presence of the following additional cardiovascular risk factors:
(Note: the risk factor(s) that were used to select the patient must be present also at the inclusion visit)
-At least one of the following:
 Symptomatic patients in CCS class II or higher at selection and inclusion visits,
 Objective evidence of myocardial ischemia induced by stress testing (within 12 months prior to selection in patients who did not undergo subsequent coronary revascularisation), either:
A positive exercise tolerance test with an horizontal or down-sloping ST segment depression of at least 2 mm (0.2 mV) for more than 0.08 sec after the J point on at least 3 consecutive complexes, in patients without abnormal ST segment at rest and without any condition that may interfere with the results,
Or inducible myocardial ischemia with reversible abnormalities involving at least 2 segments in any imaging technique,
 Discharged from hospital with a documented diagnosis of major coronary event (acute myocardial infarction or unstable angina) within 12 months prior to selection.
-Or at least two of the following:
 Documented low HDL cholesterol ( < 1 mmol/L or 40 mg/dL) and / or documented high LDL cholesterol ( > 4 mmol/L or 160 mg/dL despite lipid lowering treatment),
 Presence of type 1 or 2 diabetes mellitus treated with an oral hypoglycaemic drug or insulin,
 Presence of peripheral artery disease (symptomatic or not) documented by either: previous limb angioplasty, stenting or bypass surgery; or intermittent claudication; or ankle brachial index < 0.9 in at least one limb; or angiographic evidence of significant ( > 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant ( > 50% or reported as hemodynamically significant) peripheral artery stenosis in at least one limb,
 Current smoker (10 cigarettes or more per day on average),
 Age > 70 years.
The main non-inclusion criteria will be:
(1) Unstable cardiovascular condition,
(2) Clinical signs and / or symptoms of heart failure in NYHA class II or higher, or hospitalisation for heart failure as a primary diagnosis within the last 12 months,
(3) Contra-indications to the administration of ivabradine or current treatment with marketed ivabradine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method