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Colchicine for Acute Coronary Syndromes

Information source: Maria Vittoria Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Colchicine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Maria Vittoria Hospital

Official(s) and/or principal investigator(s):
Massimo Imazio, MD, Study Chair, Affiliation: Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy

Overall contact:
Massimo Imazio, MD, Phone: +39011439, Ext: 3391, Email: massimo_imazio@yahoo.it

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.

Clinical Details

Official title: Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall mortality, new acute coronary syndrome, and ischemic stroke.

Secondary outcome:

Mortality

New acute coronary syndrome (unstable angina and myocardial infarction)

Ischemic Stroke

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

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Massimo Imazio, MD, Phone: +39011439, Ext: 3391, Email: massimo_imazio@yahoo.it

Cardiology Dpt.Maria Vittoria Hospital, Torino 10141, Italy; Recruiting
Alessandra Chinaglia, MD, Phone: +39011439, Ext: 3226
Luisella Coda, MD, Sub-Investigator
Alessandra Chinaglia, MD, Principal Investigator

Cardiology Dpt.San Giovanni Bosco Hospital, Torino 10141, Italy; Recruiting
Patrizia Noussan, MD, Phone: +39 240, Ext: 2285
Patrizia Noussan, MD, Principal Investigator

Cardiology Dpt., Rivoli, Torino 10098, Italy; Not yet recruiting
Ferdinando Varbella, MD, Phone: 011 95511
Ferdinando Varbella, MD, Principal Investigator

Additional Information

Starting date: June 2013
Last updated: July 23, 2013

Page last updated: August 20, 2015

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