In patients who present with acute coronary syndromes, does addition of low-dose colchicine to standard medical therapy, compared to standard medical therapy alone, reduce the major adverse cardiovascular events at 12 months?

St. Vincent's Hospital Melbourne0 sites800 target enrollmentAugust 18, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 18, 2015

End Date

October 31, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

St. Vincent's Hospital Melbourne

•Age between 18 to 85 years old
•\- Patients who are admitted to the hospital with acute coronary syndromes (also known as a heart attack) \- defined by elevated troponin with ischaemic symptoms or ECG changes
•\- Presence of coronary artery disease on coronary angiogram – defined by \>30% luminal stenosis in epicardial vessel of \>2\.5mm luminal diameter, which is managed with PCI or medical therapy
•\- Able to provide written informed consent

•\- Coronary artery disease requiring surgical revascularization
•\- Pre\-existing long\-term colchicine use for other medical conditions
•\- Pre\-existing, or plan for, administration of other immunosuppressant therapy
•\- Severe liver impairment – defined by elevated serum ALT and/or AST levels twice the upper limit of normal AND total serum bilirubin level twice the upper limit of normal OR coagulopathy (INR\>1\.5\)
•\- Severe renal insufficiency – defined by eGFR\<30mL/min/1\.73m2
•\- Pre\-existing use of strong CYP3A4 or P\-glycoprotein inhibitors (eg. cyclosporine, antiretroviral drugs, antifungals, erythromycin and clarithromycin) and no other alternative medical therapy can be used
•\- Known active malignancy
•\- Known allergy or hypersensitivity to colchicine
•\- Pregnant and lactating woman or woman with childbearing potential without effective birth control methods