CompletedPhase 2ACTRN12618000809235

COCOMO-ACS Study: The Colchicine for coronary plaque modification in Acute Coronary Syndrome Study

The Colchicine for coronary plaque modification in Acute Coronary Syndrome study

Sponsor

South Australian Health and Medical Research Insititute

Enrollment

64 participants

Start Date

Dec 24, 2018

Study Type

Interventional

Conditions

Acute Coronary Syndrome Coronary Artery Disease

Summary

This research study aims to recruit 82 patients following an admission for chest pain or heart attack. The patients will be randomised to Colchicine 0.5mg daily or placebo for 12 months. This study aims to see how Colchicine acts on the coronary plaque. This medication is currently used for inflammatory conditions such as gout. It has a broad anti-inflammatory effect and previous research has shown that Colchicine helps to reduce adverse cardiovascular events in patients with coronary artery disease.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 82 Yearss

Inclusion Criteria19

Participants who undergo clinically indicated coronary angiography within 72 hours of presenting with NSTEMI.
Participants able to provide written informed consent before baseline angiography.
Male or female >= 18 and <=82 years of age at screening.
Participants must meet all of the following criteria at the qualifying coronary catheterisation procedure:
a. Angiographic evidence of coronary artery disease, with a culprit lesion identifiable
for the NSTEMI, and managed as clinically indicated
b. Target coronary artery for OCT:
i. At least one non-culprit intermediate lesion in a non-culprit
artery, determined angiographically to be 20-50% stenotic.
ii. When multiple non-culprit intermediate lesions are present, the most
angiographically severe one will be imaged.
iii. Vessel for interrogation must be accessible to the OCT catheter.
iv. Target vessel has not undergone prior percutaneous coronary intervention
(PCI) or coronary artery bypass graft (CABG) surgery, and is not a bypass
graft.
v. Target vessel is not currently a candidate for intervention or a likely
candidate for intervention over the next 12 months.
Participants able to be randomised within seven days of catheterisation..
Baseline OCT interrogation determined to be of acceptable quality, and contain a lipid-rich plaque with a FCT <=120µm and lipid arc >=90° , at review by the Atherosclerosis Imaging Core Laboratory at SAHMRI.

Exclusion Criteria15

Left main coronary disease (>50% reduction in lumen diameter by angiographic visual estimation).
Cardiogenic shock.
Heart failure (New York Heart Association (NYHA) class IV) or LVEF <= 35%.
Participants with known gout within the last 5 years.
Currently prescribed colchicine for other indication, presence of contraindications to colchicine, or known prior intolerance to colchicine. Concomitant therapy with drugs that could interact with colchicine (eg strong CYP3A4)
Dialysis or estimated glomerular infiltration rate (eGFR) < 30 ml/min/1.73m²
Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or >1.5x upper limit of normal (ULN)
Active liver disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the ULN as determined by analysis at screening
Known major active infection, or major haematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
Significant haematological abnormalities on assessment of complete blood picture: Hb <100 g/L, Plt <150x103 /µL, white cell count < 3.5x103 /µL.
History or malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma).
Female patients cannot be pregnant or breast feeding and premenopausal patients must be willing to use at least 1 highly effective method of birth control during treatment and for an additional 12 weeks after the end of treatment.
Unable to give informed consent.
Not willing or able to attend follow up visits or follow up OCT procedure at 12 months.
Any other information that the investigator considers will limit the ability of the patient to complete all study associated procedures

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants are randomly assigned to treatment or control group for 12 months. Treatment group will be given Colchicine 0.5mg once a day orally for 12 months. Control group will be given placeb

Participants are randomly assigned to treatment or control group for 12 months. Treatment group will be given Colchicine 0.5mg once a day orally for 12 months. Control group will be given placebo tablet to take once a day for 12 months. Participants will return all bottles (empty and partially used) to monitor adherence.