Multi-omics Characterization and Model Construction of Co... | NCT07064109 | Trialant

Multi-omics Characterization and Model Construction of Co... | NCT07064109 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colchicine treatment group	Experimental	Adding low-dose colchicine on the basis of standardized treatment	Drug: Colchicine 0.5 MG Oral Tablet Once Daily
control group	No Intervention	Standardized treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of responder	Resolution of Inflammation: A reduction in high-sensitivity C-reactive protein (hs-CRP) levels to <2.0 mg/L, or a decrease of ≥50% from baseline. Clinical Stability: No occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent revascularization. Ventricular Remodeling: This is assessed by parameters such as ventricular volume, wall thickness, left ventricular mass, and LVEF (Left Ventricular Ejection Fraction), measured by cardiac magnetic resonance (CMR) or echocardiography.	6 months after enrolment
Number of Participants with Advances in Coronary Artery Physiology and Function	Comparing the change in coronary QFR at baseline and one-year follow-up, the sum of QFR of the three major coronary vessels (anterior descending, circumflex, and right coronary artery) was calculated (3V-QFR), and progression in coronary physiology was defined when 3V-QFR minus baseline 3V-QFR at follow-up was ≤ -0.05	1 year after enrolment

Secondary Outcomes

Measure	Description	Time Frame
Incidence of MACE within one year	MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis	1 year after enrolment

Contacts/Locations Module