NCT05305898招募中3 期
MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
Military Institute od Medicine National Research Institute14 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年2月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
研究概览
简要总结
The aim of the study is the evaluation of the effect of metformin among the patients without diabetes, on the incidence of reintervention, unplanned revascularization, after full percutaneous coronary revascularization as a result of the first episode of the acute coronary syndrome (ACS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •ACS, according to the current definition of the European Society of Cardiology, treated with percutaneous coronary intervention with drug eluting stent implantation
- •Occupation and place of residence not causing difficulties in participating in control visits
- •Uncomplicated course of the disease (ACS) as assessed by the treating physician
- •Negative history of diabetes
- •Not taking any hypoglycaemic drugs prior to hospitalization immediately or within the last 6 months
- •HbA1c< 6,5% (assessment during hospitalization)
- •Written consent to participate in the study
排除标准
- •Significant valve disease confirmed by ECHO
- •Previous CABG
- •NYHA IV during hospitalization
- •Chronic kidney disease with GFR <60 ml / min / 1.73 m2 according to MDRD
- •ALT three times above normal according to laboratory criteria
- •Serious co-morbidities and estimated survival less than 2.5 years, as assessed by the treating physician
- •Known gastrointestinal disease that may potentially be responsible for the intolerance to metformin (e.g. inflammatory bowel disease, gastro-oesophageal reflux disease)
- •Known potential difficulties in cooperation with patients (dementia, mental disorders, distance from the place of residence, if considered potentially problematic, alcoholism)
- •Hypersensitivity to metformin
- •Pregnancy and breastfeeding
- •Patient participation in another clinical trial
研究组 & 干预措施
Metformin group
Experimental
Patients from "metformin group" will receive metformin 3 x 850 mg (after titration period) for 2 years (3 x 500 mg for first 6 weeks) with 6 months follow-up after treatment cessation.
干预措施: Metformin (Drug)
结局指标
主要结局
Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
时间窗: through study completion, an average of 5 years
Number of patients who needs an unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
次要结局
- Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up(through study completion, an average of 5 years)
- Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up(through study completion, an average of 5 years)
- Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up(through study completion, an average of 5 years)
- All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period(through study completion, an average of 5 years)
研究者
研究点 (14)
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