Effects of ivabradine on plaque progression in coronary artery disease
Research type
Research Study
Full title
Effects of ivabradine on plaque burden, morphology and composition in patients with clinically indicated coronary angiography. A randomised double-blind placebo-controlled international multicentre study.(MODIFY)
IRAS ID
134232
Contact name
Colin Berry
Contact email
Eudract number
2012-004779-38
ISRCTN Number
n/a
Research summary
The aim of this study is to investigate if a drug called ivabradine has any beneficial effect on the nature or progression of fatty plaques in the arteries of the heart of patients with coronary artery disease.
Ivabradine is a drug that lowers heart rate i.e. the number of times the heart beats per minute (bpm). It is currently approved for patients with angina and heart failure.
Studies have shown that patients with coronary artery disease and whose heart rate is greater than 70bpm are at a greater risk of events such as a heart attack. We think that slowing the heart reduces the forces exerted by blood flow on the artery walls, and that this slows the build-up of fatty plaques and also reduces the risk of plaque rupture, which can lead to a heart attack.
In this study baseline images of a ‘target’ coronary artery will be taken in patients already scheduled to undergo an angiogram. The study images will take place after routine care in an artery not requiring treatment. The imaging will be repeated at 18 months, which will involve undergoing a study related angiogram. The main imaging will be done using intravascular ultrasound (IVUS), an established technique, and if available at the centre, optical coherence tomography (OCT). From the images taken we will look for any change in plaque volume.
Patients will be prescribed either ivabradine or placebo (dummy tablet) which will be taken on top of any current heart disease treatment. This will help us to determine if lowering heart rate with ivabradine has any beneficial effect on fatty plaques.
This in an international study involving 21 countries, that will include 500 patients with a clinical indication for angiography and a resting heart rate of 70-75bpm.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0455
Date of REC Opinion
30 Oct 2013
REC opinion
Further Information Favourable Opinion