Colchicine Cardiovascular Outcomes Trial
- Conditions
- patients with atherosclerotic coronary artery disease (CAD)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-005172-28-FR
- Lead Sponsor
- Montreal Heart Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4500
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
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<br>total mortality to components of the primary endpoint, and to the composite of cardiovascular<br>death, resuscitated cardiac arrest, acute MI, or stroke. Recurrent cardiovascular events will also<br>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