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Colchicine for Acute Coronary Syndromes (COACS)

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Maria Vittoria Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Colchicine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Dpt.
  • Cardiology Dpt.Maria Vittoria HospitalRecruiting
  • Cardiology Dpt.San Giovanni Bosco HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Colchicine

Arm Description

Placebo

Colchicine 0.5mg once daily for 24 months

Outcomes

Primary Outcome Measures

Overall mortality, new acute coronary syndrome, and ischemic stroke.

Secondary Outcome Measures

Mortality
Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.
New acute coronary syndrome (unstable angina and myocardial infarction)
Ischemic Stroke

Full Information

First Posted
July 21, 2013
Last Updated
July 23, 2013
Sponsor
Maria Vittoria Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01906749
Brief Title
Colchicine for Acute Coronary Syndromes
Acronym
COACS
Official Title
Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Vittoria Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute coronary syndrome, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
Colchicine 0.5mg once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
0.5mg once daily orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Overall mortality, new acute coronary syndrome, and ischemic stroke.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mortality
Description
Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.
Time Frame
24 months
Title
New acute coronary syndrome (unstable angina and myocardial infarction)
Time Frame
24 months
Title
Ischemic Stroke
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Imazio, MD
Phone
+39011439
Ext
3391
Email
massimo_imazio@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiology Dpt.
City
Rivoli
State/Province
Torino
ZIP/Postal Code
10098
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferdinando Varbella, MD
Phone
011 95511
First Name & Middle Initial & Last Name & Degree
Ferdinando Varbella, MD
Facility Name
Cardiology Dpt.Maria Vittoria Hospital
City
Torino
ZIP/Postal Code
10141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Chinaglia, MD
Phone
+39011439
Ext
3226
First Name & Middle Initial & Last Name & Degree
Luisella Coda, MD
First Name & Middle Initial & Last Name & Degree
Alessandra Chinaglia, MD
Facility Name
Cardiology Dpt.San Giovanni Bosco Hospital
City
Torino
ZIP/Postal Code
10141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Noussan, MD
Phone
+39 240
Ext
2285
First Name & Middle Initial & Last Name & Degree
Patrizia Noussan, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32648087
Citation
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.
Results Reference
derived

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Colchicine for Acute Coronary Syndromes

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