CTRI/2010/091/000132CompletedPhase 3
Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease ( SIGNIFY)
Institut de Recherches Internationales Servier IRIS0 sites16,850 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 16,850
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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:
- •Â Symptomatic patients in CCS class II or higher at selection and inclusion visits,
- •Â 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,
- •Â 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:
- •Â 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),
- •Â Presence of type 1 or 2 diabetes mellitus treated with an oral hypoglycaemic drug or insulin,
- •Â 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,
- •Â Current smoker (10 cigarettes or more per day on average),
- •Â Age > 70 years.
Exclusion Criteria
- •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.
Investigators
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