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Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure (SIGNIFY)
Servier Protocol Code:
CL3-16257-083
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02446990
EudraCT Number:
2009-011360-10
Find a recruiting site
How to participate to the study?
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 2 locations
Study description
The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
Official title: Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure. A Randomised Double-blind Placebo-controlled International Multicenter Study. Study Assessing the Morbi-mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease
Results
English (USA)Conditions
Coronary Artery Disease
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Ivabradine
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL3-16257-083
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
55 years and older
(Adult, Older Adult)
Sexes
Male/FemaleAccepts Healthy Volunteers
No- * Evidence of coronary artery disease
- * Sinus rhythm and resting heart rate equal or higher than 70 bpm
- * Unstable cardiovascular condition
- * Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Ivabradine
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Ivabradine
5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Placebo
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Keywords
Additional Relevant MeSH Terms Glioma
Coronary Artery Disease