NCT00754819

Brief Summary

The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

September 16, 2008

Last Update Submit

October 7, 2009

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of low dose colchicine on hs-CRP.

    30 days

Secondary Outcomes (1)

  • To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Colchicine 1mg daily oral

Drug: Colchicine

2

PLACEBO COMPARATOR

Placebo 1 capsule daily oral

Drug: Placebo

Interventions

ColchicineDRUG

1mg once daily

1
PlaceboDRUG

1 capsule daily

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with a diagnosis of acute coronary syndrome who are \> 18 years old and who do not have any contraindication to colchicine.

You may not qualify if:

  • Contraindication to colchicine including any of the following:
  • hypersensitivity to colchicine
  • severe renal, hepatic or gastrointestinal disorder
  • blood dyscrasias (myelodysplasia cytopenias etc)
  • Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
  • Known severe liver disease and/or elevated transaminases \> 1.5x the upper limit of normal
  • Estimated GFR \< 50 ml/min
  • Pregnant or lactating women or women not protected by a reliable contraception method
  • Current treatment with colchicine at enrollment
  • Active infection or systemic inflammation eg active rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • John Eikelboom, FRACP FRCPA

    McMaster University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

CA(1)