ESCALATE
Research type
Research Study
Full title
ESCALATion of medical therapy following multimodality plaque Evaluation in high-risk Chronic Coronary Syndromes
IRAS ID
1007183
Contact name
Nilesh Pareek
Contact email
ISRCTN Number
ISRCTN46375134
Research summary
Despite recent advances, coronary artery disease (CAD) remains the main cause of death worldwide. CAD occurs when the arteries bringing blood to your heart become narrowed by a build-up of fatty material within their walls. If this occurs gradually, it can cause chest discomfort i.e., angina. In a heart attack, the artery wall becomes inflamed and splits causing blood clot formation and an abrupt blockage of flow, resulting in severe pain and damaged heart muscle. Current treatments focus on reducing cholesterol, slowing the build-up of fatty material, and rapidly restoring blood-flow during a heart attack. Chronic inflammation, acting in tandem with other risk factors, has been identified as playing a central role in CAD progression and its acute manifestations.
Colchicine is a safe, well tolerated, anti-inflammatory therapy used in the treatment of gout and other inflammatory conditions. Daily treatment with low-dose colchicine has proven effective in reducing rates of heart attack and death in large clinical trials, but use in routine practice remains low. A contributing factor to this reticence is uncertainty regarding the mechanism through which colchicine provides benefit.
ESCALATE is designed to address this knowledge-gap. Using traditional markers of clinical-risk and state-of-the-art imaging from inside the coronary artery, we will identify patients with CAD and greatest clinical risk. Eligible patients, already established on statin therapy will be allocated to a six-month course of low-dose Colchicine plus usual care, or usual care only. Researchers, participants, and usual clinicians will be aware of the allocation during the study.
After six months, we will assess the impact of colchicine on the appearance of individual coronary artery lesions, blood flow in the large and small blood vessels of the heart and markers of immune cell function. This study will provide a detailed assessment of colchicine and its mechanism of action in CAD.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0082
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Favourable Opinion