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RECRUITING
NCT04181996
PHASE3

Canadian Study of Arterial Inflammation in Patients With Diabetes and Vascular Events: EvaluatioN of Colchicine

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

Summary

Cardiovascular Disease (CVD) is a leading cause of death in the developed world. Atherosclerosis causes plaques in the blood vessels and is a common form of CVD. Inflammation is now recognized as a major cause of atherosclerosis. Therapies that target inflammation are being examined as a potential treatment option. Imaging to detect inflammation may be a solution to understand mechanisms and to optimize patient selection and outcomes for these drugs. Fluorodeoxyglucose (FDG) PET imaging can detect inflammation in the plaque and identify patients vulnerable to plaque rupture which cause events such as myocardial infarctions (MI) and strokes. The primary objective of this proposal(CADENCE) is to determine if the drug colchicine has an effect on plaque inflammation in patients at high risk for events (patients with diabetes or pre-diabetes and recent myocardial infarction, stroke or transient ischemic attacks (TIAs)). This mechanistic and proof-of-concept study will set the stage for future studies that will determine if inflammation imaging can be integrated into clinical practice to personalize decisions for anti-inflammation therapies.

Official title: The Canadian Study of Arterial Inflammation in Patients With Diabetes and Recent Vascular Events: EvaluatioN of Colchicine Effectiveness (CADENCE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2020-08-01

Completion Date

2025-08-14

Last Updated

2024-04-22

Healthy Volunteers

No

Interventions

DRUG

Colchicine Oral Product

Patients will be randomized to receive either placebo or colchicine

DRUG

Placebo oral capsule

Patents will be randomized to receive either placebo or colchicine

Locations (2)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada