Colchicine for Acute Coronary Syndromes (COACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Maria Vittoria Hospital
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
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

Contacts
Contact: Massimo Imazio, MD +39011439 ext 3391 massimo_imazio@yahoo.it

Locations
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         
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
Study Chair: Massimo Imazio, MD Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
  More Information

No publications provided

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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014