Acute coronary syndrome, Ischaemic heart disease, Atherosclerosis
Conditions
Interventions
Study sites:
• National Hospital of Sri Lanka, Colombo 10
• CLINMARC, National Hospital of Sri Lanka, Colombo 10
• Kandy National Hospital
• Colombo North Teaching Hospital, Ragama
• Negombo Distr
Sponsors
The University of Sydney
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged equal or greater than 18 years 2. Presentation with an Acute Coronary Syndrome (defined as acute myocardial infarction, with or without electrocardiographic evidence of ST-segment elevation, or high-risk unstable angina) 3. hs-CRP equal or greater than 1.0mg/L (at time of registration 4 - 52 weeks after discharge for an ACS event) 4. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 5. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Any known intolerance to Colchicine 2. Pre-existing Colchicine treatment for greater than 7 days within the last 3 months 3. Current active myopathy with CK >3 x upper limit of normal 4. Severe liver disease or aminotransferase level > 3x upper limit of normal, within the last 3 months 5. Persistent blood dyscrasia (white cell count or platelet count < lower limit of normal), within the last 3 months 6. Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73m2 at time of registration 7. Prior or current therapy with a strong CYP3A4 inhibitor or inducer or calcineurin inhibitor 8. Active autoimmune disease or chronic inflammatory bowel disease (defined as any disease requiring long-term or frequent immunosuppression), where use of infliximab, cyclosporin, or azathioprine is current or likely. 9. Haematological malignancy which remains uncured or antineoplastic therapy within the last 3 months 10. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 11. Any known comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s) or may compromise assessment of key outcomes. 12. Life expectancy of less than 3 years 13. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol. 14. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Sexually active men must ensure that their partners use adequate contraception at all times when the trial medication is being consumed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of major adverse cardiovascular events (MACE); a composite of ACS including myocardial infarction, urgent unscheduled revascularization, CV death, and non-fatal stroke The outcome will assess incidence using, regular follow-up and self-reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists. [Follow-up visits during the study treatment period are planned at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (primary timepoint) and annually until end of study] | — |
Secondary
| Measure | Time frame |
|---|---|
| The individual components of MACE - ACS including myocardial infarction (specifically Type 1 MI) - Urgent unscheduled revascularisation (carotid/ coronary) - Cardiovascular mortality - Non-fatal stroke The outcome will assess incidence using, regular follow-up and self-reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists. [Follow-up visits during the study treatment period are planned at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (primary timepoint) and annually until end of study] Non-cardiovascular mortality. The outcome will assess incidence using, regular follow-up and self-reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists. [Follow-up visits during the study treatment period are planned at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (primary timepoint) and annually until end of study] All-cause mortality. The outcome will assess incidence using, regular follow-up and self-reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists. [Follow-up visits during the study treatment period are planned at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (primary timepoint) and annually until end of study] Difference in hs-CRP from baseline to end of active run-in. The outcome will assess incidence using, regular follow-up and self-reported events or hospitalisations, reporting of events by family members or other contacts, review of patient medical records and admission summaries and correspondence from GPs and other specialists. [Follow-up v | — |
Countries
Australia,Chile,Sri Lanka
Contacts
Public ContactProfessor Asita de Silva
Senior Professor of Pharmacology
Outcome results
None listed