The effect of Colchicine on Cardiovascular Outcomes in Acute Coronary Syndrome Study (The COLCARDIO-ACS Study)

Phase 3

Recruiting

• Conditions: Acute coronary syndrome; Ischaemic heart disease; Atherosclerosis; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616000400460
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-29
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3000

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) and commenced on optimal medical therapy
3. hs-CRP equal or greater than 2mg/L (at time of registration 4 - 52 weeks after discharge for an Acute Coronary Syndrome 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

COLCHICINE-COG
1. Be enrolled in COLCARDIO-ACS;
2. Be aged 40 - 65 years (at the time of enrolment);
3. Be willing and able to comply with sub-study visit schedule and nature of required
assessments; and
4. Provide signed written informed consent

Exclusion Criteria

1. Any known intolerance to Colchicine
2. Pre-existing Colchicine treatment within the last 3 months
3. Any known myopathy (any grade or myopathy in present or prior history within the last 3 months or 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. Blood dyscrasia (white cell count or platelet count < lower limit of normal), within the last 3 months
6. Estimated glomerular filtration rate (eGFR) <45 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)
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. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

COLCHICINE-COG
1. Suspected or established dementia diagnosis (MMSE <23);
2. Intellectual or developmental disability;
3. History of head injury with loss of consciousness >30 minutes;
4. History of major neurological illness (e.g. stroke, epilepsy);
5. History of psychiatric illness (other than affective disorder e.g. schizophrenia, bipolar
disorder);
6. History of electroconvulsive therapy or deep brain stimulation;
7. Current/past alcohol or substance dependence (other than nicotine);
8. Any known medical condition which may affect cognition (e.g. cancer, chronic fatigue
syndrome); and/or
9. Contraindications to magnetic resonance imaging scanning (e.g. aneurysm clip,
pacemaker, etc.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified