ESCALATE will provide a thorough investigation of how anti-inflammatory therapy, with low-dose colchicine, affects patients with stable coronary artery disease. Using traditional clinical risk factors and multimodality intracoronary imaging, the investigators will identify patients with the greatest clinical risk.
Participants will undergo repeat multimodality intracoronary imaging assessment at 6 months to measure the impact once-daily low-dose colchicine therapy on the structure and function of coronary arteries.
This study will provide valuable insights into how anti-inflammatory therapies, such as colchicine, may improve outcomes in patients with coronary artery disease.
Ability to provide written informed consent
Age 18 to 90 years old
Male, or female of non-child-bearing potential
Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation
Women who are pregnant, breast feeding, or of child-bearing potential
Symptoms of unstable angina, characterised as: angina at rest; new onset of severe exertional angina (CCS grade III or higher for <4 weeks); or distinct, sudden, intensification of previously stable angina
Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation <4 weeks from recruitment
Previous coronary artery bypass grafting
Parallel
Colchicine 0.5 MG
DrugLow dose daily colchicine
Absolute change in minimal fibrous cap thickness
The absolute change (µm) in minimal fibrous cap thickness, in a defined arterial region of interest, as assessed by OCT
Major adverse clinical events
Major adverse cardiovascular event (MACE): Composite of cardiovascular death, non-fatal MI, unplanned revascularisation and ischaemic stroke
Acute kidney injury
AKI secondary to contrast induced nephropathy
Major bleeding events (BARC 3-5)
Periprocedural major bleeding events (BARC 3-5)
Hospitalisation with serious infection
Hospitalisation requiring intravenous antibiotics
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King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
