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Colchicine for Acute Coronary Syndromes (COACS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Maria Vittoria Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
ClinicalTrials.gov Identifier:
NCT01906749
First received: July 21, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose
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.

Condition Intervention Phase
Acute Coronary Syndrome
Drug: Colchicine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Maria Vittoria Hospital:

Primary Outcome Measures:
  • Overall mortality, new acute coronary syndrome, and ischemic stroke. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ischemic Stroke [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Active Comparator: Colchicine
Colchicine 0.5mg once daily for 24 months
Drug: Colchicine
0.5mg once daily orally

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906749

Locations
Italy
Cardiology Dpt.
Rivoli, Torino, Italy, 10098
Cardiology Dpt.Maria Vittoria Hospital
Torino, Italy, 10141
Cardiology Dpt.San Giovanni Bosco Hospital
Torino, Italy, 10141
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
Study Chair: Massimo Imazio, MD Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
  More Information

Responsible Party: Massimo Imazio, MD, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01906749     History of Changes
Other Study ID Numbers: 27/06/13  2013-001415-78 
Study First Received: July 21, 2013
Last Updated: July 23, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Maria Vittoria Hospital:
Acute coronary syndrome
Colchicine

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016