Clinical Trial: Colchicine for Acute Coronary Syndromes
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
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 Summary: 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.
Sponsor: Maria Vittoria Hospital
Current Primary Outcome: Overall mortality, new acute coronary syndrome, and ischemic stroke. [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mortality [ Time Frame: 24 months ]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 ]
- Ischemic Stroke [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Maria Vittoria Hospital
Dates:
Date Received: July 21, 2013
Date Started: June 2013
Date Completion: June 2016
Last Updated: July 23, 2013
Last Verified: July 2013
