Colchicine Cardiovascular Outcomes Trial (COLCOT)
Condition: Coronary Artery Disease; Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Intervention: colchicine; colchicine placebo
Intervention description: 0.5 mg tablet taken once a day; sugar pill manufactured to mimic colchicine 0.5 mg tablet
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4745.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study evaluates whether long-term treatment with colchicine reduces rates of
      cardiovascular events in patients after myocardial infarction. Patients who have suffered a
      documented acute myocardial infarction within the last 30 days, are treated according to the
      national guidelines and after having completed any planned percutaneous revascularization
      procedures associated with their initial infarction will receive either colchicine (0.5 mg
      per day) or matching placebo (1:1 allocation ratio) for an estimated 2 years period or until
      the target of 301 primary endpoints has been reached.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females of at least 18 years of age capable and willing to provide informed
             consent

          -  Patient must have suffered a documented acute myocardial infarction within the last 30
             days

          -  Patient must be treated according to national guidelines (including anti-platelet
             therapy, statin, renin-angiotensin-aldosterone system inhibitor (preferably
             angiotensin-converting enzyme) and beta-blocker when indicated)

          -  Patient must have completed any planned percutaneous revascularization procedures
             associated with his or her qualifying myocardial infarction

          -  Female patient is either not of childbearing potential, defined as postmenopausal for
             at least one year or surgically sterile, or is of childbearing potential and
             practicing at least one method of contraception and preferably two complementary forms
             of contraception

          -  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

        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 this study

          -  Patient with a Type 2 index MI (secondary to ischemic imbalance)

          -  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 creatine
             phosphokinase level greater than 3 times the upper limit of normal (unless due to
             myocardial infarction 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 less than 115 grams/L, white
             blood cell count less than 3.0 X 10(9)/L,platelet count less than 110 X 10(9)/L,
             alanine aminotransferase greater than 3 times the upper limit of normal, total
             bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert
             syndrome, which is allowed), creatinine greater than 2 times the upper limit of normal

          -  Patient with a history of cirrhosis, chronic active hepatitis or sever 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 plan 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 enrollment

          -  Patient with 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 he investigator, for any reason, to be an unsuitable
             candidate for the study