EUCTR2014-005172-28-PT进行中（未招募）1 期
Colchicine Cardiovascular Outcomes Trial (COLCOT) - COLCOT
Montreal Heart Institute0 个研究点目标入组 4,500 人开始时间: 2015年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and females, at least 18 years of age , capable and willing to provide informed
- •? 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
排除标准
- •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 with a Type 2 index MI (secondary to ischemic imbalance);
- •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 known parameters, 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
- •- 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
研究者
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