Colchicine for Acute Coronary Syndromes (COACS)
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ClinicalTrials.gov Identifier: NCT01906749 |
Recruitment Status : Unknown
Verified July 2013 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Drug: Colchicine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial. |
Study Start Date : | June 2013 |
Estimated Primary Completion Date : | June 2016 |
Estimated Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo
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Drug: Placebo |
Active Comparator: Colchicine
Colchicine 0.5mg once daily for 24 months
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Drug: Colchicine
0.5mg once daily orally |
- Overall mortality, new acute coronary syndrome, and ischemic stroke. [ Time Frame: 24 months ]
- Mortality [ Time Frame: 24 months ]Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.
- New acute coronary syndrome (unstable angina and myocardial infarction) [ Time Frame: 24 months ]
- Ischemic Stroke [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >18years
- Acute coronary syndrome (unstable angina or acute myocardial infarction)
- Life expectancy> 2 years
- Absence of contraindications to colchicine
Exclusion Criteria:
- Colchicine treatment for any cause
- Severe liver disease
- Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2
- Known cancer
- Chronic inflammatory bowel disease
- treatment with cyclosporine
- allergy or hypersensitivity to colchicine
- pregnancy or lactating woman or woman with childbearing potential without valid contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906749
Contact: Massimo Imazio, MD | +39011439 ext 3391 | massimo_imazio@yahoo.it |
Italy | |
Cardiology Dpt. | Not yet recruiting |
Rivoli, Torino, Italy, 10098 | |
Contact: Ferdinando Varbella, MD 011 95511 | |
Principal Investigator: Ferdinando Varbella, MD | |
Cardiology Dpt.Maria Vittoria Hospital | Recruiting |
Torino, Italy, 10141 | |
Contact: Alessandra Chinaglia, MD +39011439 ext 3226 | |
Sub-Investigator: Luisella Coda, MD | |
Principal Investigator: Alessandra Chinaglia, MD | |
Cardiology Dpt.San Giovanni Bosco Hospital | Recruiting |
Torino, Italy, 10141 | |
Contact: Patrizia Noussan, MD +39 240 ext 2285 | |
Principal Investigator: Patrizia Noussan, MD |
Study Chair: | Massimo Imazio, MD | Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy |
Responsible Party: | Massimo Imazio, MD, Maria Vittoria Hospital |
ClinicalTrials.gov Identifier: | NCT01906749 |
Other Study ID Numbers: |
27/06/13 2013-001415-78 ( EudraCT Number ) |
First Posted: | July 24, 2013 Key Record Dates |
Last Update Posted: | July 24, 2013 |
Last Verified: | July 2013 |
Acute coronary syndrome Colchicine |
Acute Coronary Syndrome Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
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