ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes
NCT Number: NCT06469528
Acronym: ESCALATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Coronary Artery Disease
Interventions: DRUG: Colchicine 0.5 MG
Sponsor: King's College Hospital NHS Trust
Collaborators: King's College London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2026-10-05

Summary:
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.

Primary Outcome Measures: 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, 6months
Secondary Outcome Measures: Major adverse clinical events, Major adverse cardiovascular event (MACE): Composite of cardiovascular death, non-fatal MI, unplanned revascularisation and ischaemic stroke, 6 months|Acute kidney injury, AKI secondary to contrast induced nephropathy, 6 months|Major bleeding events (BARC 3-5), Periprocedural major bleeding events (BARC 3-5), 6 months|Hospitalisation with serious infection, Hospitalisation requiring intravenous antibiotics, 6 months|% change in minimal fibrous cap thickness, Percentage change in minimal fibrous cap thickness, as determined by OCT, in a defined arterial region of interest, 6 months|% change in maximal lipid arc, Percentage change in lipid arc, as determined by OCT, in a defined arterial region of interest, 6 months|Percentage change in lipid index, Percentage change in lipid index, as determined by OCT, in a defined arterial region of interest, 6 months|Absolute change in maximum lipid core burden index in a 4-mm segment (maxLCBI4mm), Absolute change in maximum lipid core burden index in a 4-mm segment (maxLCBI4mm), as determined by NIRS, in a defined arterial region of interest, 6 months|Relative change (%) in maximum lipid core burden index in a 4-mm segment (maxLCBI4mm), Relative change (%) in maximum lipid core burden index in a 4-mm segment (maxLCBI4mm), as determined by NIRS, in a defined arterial region of interest, 6 months|Change in total atheroma volume, Change in percent atheroma volume, as determined by IVUS, in a defined arterial region of interest, 6 months|Absolute and percentage change in coronary flow reserve (CFR), Absolute and percentage change in coronary flow reserve (CFR), measured in artery of interest, 6 months|Absolute and percentage change in index of microvascular resistance (IMR), Absolute and percentage change in index of microvascular resistance (IMR), measured in artery of interest, 6 months|Absolute and percentage change in vessel fractional flow reserve (FFR), Absolute and percentage change in vessel fractional flow reserve (FFR), measured in artery of interest, 6 months|Percentage change in high-sensitivity c-reactive protein (hs-CRP), Percentage change in high-sensitivity c-reactive protein (hs-CRP), 6 months