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Colchicine for Acute Coronary Syndromes

NCT01906749 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-07-24

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Colchicine

0.5mg once daily orally

DRUG

Placebo

Sponsors & Collaborators

  • Maria Vittoria Hospital

    lead OTHER

Principal Investigators

  • Massimo Imazio, MD · Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906749 on ClinicalTrials.gov