Colchicine Cardiovascular Outcomes Trial (COLCOT)

NCT02551094 | Completed Phase 3 Results DMC

• 1 other identifier: MHIPS-003
• Study Type: interventional
• Target: 4,745
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization

  The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.

  From randomization to occurence of first event, assessed up to 3.5 years

Secondary Outcomes (7)

• Death (Total Mortality)

  From randomization to death, assessed up to 3.5 years

• Cardiovascular Death

  From randomization to death, assessed up to 3.5 years

• Resuscitated Cardiac Arrest

  From randomization to event, assessed up to 3.5 years

• Myocardial Infarction

  From randomization to event, assessed up to 3.5 years

• Stroke

  From randomization to event, assessed up to 3.5 years

Other Outcomes (4)

• First Event of Deep Venous Thrombosis or Pulmonary Embolus

  From randomization to occurence of first event, assessed up to 3.5 years

• Atrial Fibrillation

  From randomization to event, assessed up to 3.5 years

• Heart Failure Hospitalization

  From randomization to event, assessed up to 3.5 years

Study Arms (2)

colchicine

ACTIVE COMPARATOR

0.5 mg tablet of colchicine taken once a day

Drug: colchicine

colchicine placebo

PLACEBO COMPARATOR

0.5 mg tablet of placebo taken once a day

Drug: colchicine placebo

Interventions

colchicine DRUG

0.5 mg tablet taken once a day

Also known as: no other name

colchicine

colchicine placebo DRUG

sugar pill manufactured to mimic colchicine 0.5 mg tablet

Also known as: no other name

colchicine placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Related Publications (2)

• Bouabdallaoui N, Tardif JC, Waters DD, Pinto FJ, Maggioni AP, Diaz R, Berry C, Koenig W, Lopez-Sendon J, Gamra H, Kiwan GS, Blondeau L, Orfanos A, Ibrahim R, Gregoire JC, Dube MP, Samuel M, Morel O, Lim P, Bertrand OF, Kouz S, Guertin MC, L'Allier PL, Roubille F. Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J. 2020 Nov 7;41(42):4092-4099. doi: 10.1093/eurheartj/ehaa659.

  PMID: 32860034 DERIVED

• Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

  PMID: 31733140 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jean-Claude Tardif (Principle Investigator)
• Organization: Montreal Heart Institute

jean-claude.tardif@icm-mhi.org

514-376-3330

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Andreas Orfanos, MD

  Montreal Health Innovations Coordinating Centre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 16, 2015
• Study Start: December 4, 2015
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

CA (1)