Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Anti-Inflammatory Effect of Colchicine
研究概览
简要总结
To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)
详细描述
Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial infarction which may benefit in short and long term outcome in patients. The short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years to 80 years old
- •STEMI within 24 hours of admission to Pusat Perubatan UKM & undergoing revascularization therapy (percutaneous coronary intervention) during admission
- •STEMI is diagnosed when there is:
- •ST elevation of ≥1 mm in 2 contiguous leads or
- •a new onset LBBB in the resting ECG
- •in a patient with ischaemic type chest pains of > 30 minutes and
- •accompanied by a rise and fall in cardiac biomarkers (CPG MALAYSIA STEMI 2019, 4th Edition)
排除标准
- •Pre-existing severe heart failure with left ventricular ejection fraction less than 35%
- •Clinically unstable (Intubated or double inotropic support)
- •Refuse or not suitable for cardiac revascularization therapy
- •Anaemia induced Angina (Hb < 9 g/dL)
- •Ongoing sepsis requiring antibiotic
- •Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 & 7)
- •Active Covid-19 Infection (< 7 days for Category 1-3, < 10 days for category 4-5)
- •Stroke within previous 3 months
- •Coronary bypass surgery either within the previous 3 years or planned
- •Active malignancy or treated malignancy within 7 years
- •Active Inflammatory bowel disease on treatment
- •Active Neuromuscular disease on treatment
- •Chronic kidney disease (CKD stage 4 - eGFR < 30 mL/min/1.73 m2)
- •Severe hepatic disease (ALT > 3X upper limit normal, Bilirubin > 2X upper limit normal)
- •Active drug or alcohol abuse on therapy
- •On long term or recent systemic glucocorticoid therapy within 3 months
- •Pregnancy or breastfeeding
- •Known sensitivity to colchicine or multivitamin tablet
- •Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc)
- •Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)
研究组 & 干预措施
Colchicine Post ST Elevation Myocardial Infarction (STEMI)
32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days
干预措施: Oral Colchicine 0.6 mg (Drug)
Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days
干预措施: Oral Pyridoxine 10 mg (Drug)
结局指标
主要结局
Anti-Inflammatory Effect of Colchicine
时间窗: 3-7 days
Serum Troponin I change from arrival to discharge
Major Adverse Cardiac Events (MACE)
时间窗: 3 months
Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
次要结局
- Trans thoracic Echo cardiogram parameters(3 months)
- Safety of colchicine(1 month)