Efficacy and safety of Ivabradine (Coralan) in the treatment of stable angina pectoris

Phase 4

Completed

• Conditions: Health Condition 1: null- Stable Angina Pectoris

• Registration Number: CTRI/2010/091/003007
• Lead Sponsor: Serdia Pharmaceuticals India Pvt Ltd Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified