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Colchicine in Vascular Inflammation Assessed With PET Imaging

NCT02162303 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-02-21

No results posted yet for this study

Summary

The purpose of this trial is to assess the effects of colchicine on vascular inflammation measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic investigation will be performed to identify genetic biomarkers of patient response.

Conditions

  • Atherosclerotic Vascular Disease

Interventions

DRUG

Colchicine

0.6 mg a day of active treatment or placebo for 24 weeks

DRUG

Placebo

Sugar,given once daily, over 6 months.To mimic active treatment

Sponsors & Collaborators

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Jean-Claude Tardif, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2016-01-31

Countries

  • Canada

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 NCT02162303 on ClinicalTrials.gov