patients with atherosclerotic coronary artery disease (CAD)
Conditions
Interventions
Product Name: colchicine
Pharmaceutical Form: Coated tablet
INN or Proposed INN: COLCHICINE
CAS Number: 64-86-8
Other descriptive name: COLCHICINE
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Montreal Heart Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2) at end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) 2) at end of the study | — |
Countries
Argentina, Canada, Chile, Colombia, Czech Republic, France, Germany, Italy, Lebanon, Portugal, Spain, Tunisia, United Kingdom
Contacts
Public ContactMylene Provencher
Montreal Health Innovations Coordinating Center, a division of Montreal Heart Institute
Outcome results
None listed