Health Condition 1: null- Stable Angina Pectoris
Conditions
Interventions
Intervention1: Ivabradine: 5 mg/ 7.5 mg bid for 12 months
Control Intervention1: NIL: NIL
Sponsors
Serdia Pharmaceuticals India Pvt Ltd Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female patients between 18 years to 75 years of age 2) Confirmed case of Coronary Artery Disease (CAD) documented by either of the following: a. History of stable angina (on treatment with anti-anginal drug for at least last 3 months prior to inclusion) b. Previous myocardial infarction of > 6 months duration prior to inclusion c. Positive exercise tolerance test (ETT, based on available report) d. Previous revascularization of > 6 months prior to inclusion (percutaneous or surgical) e. Angiographic evidence that one or more major coronary arteries had narrowed by 50% or more (ETT, based on available report) 3) Given written informed consent to participate in the study and agree for regular follow-up
Exclusion criteria
Exclusion criteria: 1) Resting heart rate below 60 beats per minute 2) Heart failure 3) History of myocardial infarction/ stroke of < 6 months prior to inclusion 4) AV block, SA block and/or sick-sinus syndrome 5) Symptomatic hypotension 6) Unstable/ Prinzmetal angina 7) Atrial fibrillation/ flutter, arrhythmias 8) Severe hepatic abnormalities 9) Intolerance and any other clinical condition likely to interfere in the study conduct 10) History of drug abuse/ alcohol abuse 11) Pregnancy/ Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Ivabradine treatment in the treatment of stable anginaTimepoint: Month 0, Month 3, Month 6, Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and acceptability of the treatment with ivabradine in stable anginaTimepoint: Month 0 to Month 12 | — |
Countries
India
Contacts
Public ContactDr. Manjusha Rajarshi
Outcome results
None listed