Colchicine Cardiovascular Outcomes Trial

Phase 1

Conditions: patients with atherosclerotic coronary artery disease (CAD)
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-005172-28-ES

Lead Sponsor: Montreal Heart Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4500

Inclusion Criteria

Males and females, at least 18 years of age , capable and willing to provide informed
consent;
? Patient must have suffered a documented acute MI within the last 30 days;
? Patient must be treated according to national guidelines (including anti-platelet therapy,
statin, renin-angiotensin-aldosterone system (RAAS) inhibitor (preferably angiotensinconverting-
enzyme (ACE) inhibitor) and beta-blocker when indicated);
? Patient must have completed any planned percutaneous revascularization procedures
associated with his/her qualifying MI;
? Female patient is either not of childbearing potential, defined as postmenopausal for at
least 1 year or surgically sterile, or is of childbearing potential and practicing at least one
method of contraception and preferably two complementary forms of contraception
including a barrier method (e.g. male or female condoms, spermicides, sponges, foams,
jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after
study completion;
Patient is judged to be in good general health as determined by the principal investigator;
? Patient must be able and willing to comply with the requirements of this study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

Patient with a poorly controlled medical condition, such as New York Heart Association
Class III-IV heart failure, a left ventricular ejection fraction of less than 35%, recent
stroke (within the past 3 months), or any other condition which, in the opinion of the
investigator, would put the patient at risk if participating in the study
Patient with a prior coronary artery bypass graft within the past 3 years, or planned;
? Patient currently in cardiogenic shock or with hemodynamic instability;
? Patient with a history of cancer or lymphoproliferative disease within the last 3 years,
other than a successfully treated non-metastatic cutaneous squamous cell or basal cell
carcinoma and/or localized carcinoma in situ of the cervix;
? Patient with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or patient
with chronic diarrhea;
? Patient with pre-existent progressive neuromuscular disease or patient with CPK level > 3
times the upper limit of normal (unless due to MI, which is allowed) as measured within
the past 30 days and determined to be non-transient through repeat testing
Patient with any of the following as measured within the past 30 days, and determined to
be non-transient through repeat testing:
- hemoglobin < 115g/L,
- white blood cell count < 3.0 X 109/L,
- platelet count <110 X 109/L,
- ALT > 3 times the upper limit of normal (ULN),
- total bilirubin > 2 times ULN (unless due to Gilbert syndrome, which is
allowed)
- Creatinine > 2 times ULN;
? Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
? Female patient who is pregnant, or breast-feeding or is considering becoming pregnant
during the study or for 6 months after the last dose of study medication;
? Patient with a history of clinically significant drug or alcohol abuse in the last year;
? Patient is currently using or plans to begin chronic systemic steroid therapy (oral or
intravenous) during the study (topical or inhaled steroids are allowed);
? Patient currently taking colchicine for other indications (mainly chronic indications
represented by Familial Mediterranean Fever or gout). There is no wash-out period
required for patients who have been treated with colchicine and stopped treatment prior
to enrolment;
Patient with a history of an allergic reaction or significant sensitivity to colchicine;
? Patient who has used an investigational chemical agent less than 30 days or 5 half-lives
prior to the Screening visit (whichever is longer);
? Patient is considered by the investigator, for any reason, to be an unsuitable candidate for
the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction (MI);Secondary Objective: The secondary objective is to determine the safety of long-term treatment with colchicine in this patient population.;Primary end point(s): The primary endpoint will be the time from randomization to the first event of cardiovascular death, resuscitated cardiac arrest, acute MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.;Timepoint(s) of evaluation of this end point: 1) at 50% of primary endpoints ( interim analysis)<br>2) at end of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will consist of times to total mortality to components of the primary endpoint, and to the composite of cardiovascular death, resuscitated cardiac arrest, acute MI, or stroke. Recurrent cardiovascular events will also be evaluated.;Timepoint(s) of evaluation of this end point: 1) at 50% of primary endpoints ( interim analysis)<br>2) at end of the study