Colchicine for Acute Coronary Syndromes
COACS
2 other identifiers
interventional
500
1 country
3
Brief Summary
Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2013
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 21, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 24, 2013
July 1, 2013
3 years
July 21, 2013
July 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall mortality, new acute coronary syndrome, and ischemic stroke.
24 months
Secondary Outcomes (3)
Mortality
24 months
New acute coronary syndrome (unstable angina and myocardial infarction)
24 months
Ischemic Stroke
24 months
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Colchicine
ACTIVE COMPARATORColchicine 0.5mg once daily for 24 months
Interventions
Eligibility Criteria
You may qualify if:
- \>18years
- Acute coronary syndrome (unstable angina or acute myocardial infarction)
- Life expectancy\> 2 years
- Absence of contraindications to colchicine
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cardiology Dpt.
Rivoli, Torino, 10098, Italy
Cardiology Dpt.Maria Vittoria Hospital
Torino, Torino, 10141, Italy
Cardiology Dpt.San Giovanni Bosco Hospital
Torino, Torino, 10141, Italy
Related Publications (1)
Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.
PMID: 32648087DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Massimo Imazio, MD
Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 21, 2013
First Posted
July 24, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 24, 2013
Record last verified: 2013-07