NCT03980990Unknown4 期
Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Lactic Acidosis
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.
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
- 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
- •On metformin therapy
- •Angiography for ACS or elective non-ACS related indications
- •Informed consent received
排除标准
- •Cardiogenic shock prior to randomization
- •Cardiac arrest prior to randomization
- •Established severe CKD (eGFR<30, or on dialysis)
- •Chronic liver disease
- •Need for CABG within 48 hours of hospitalization
- •Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
研究组 & 干预措施
Metformin Continuation
Experimental
Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.
干预措施: Metformin (Drug)
结局指标
主要结局
Lactic Acidosis
时间窗: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
Lactate Level \>5 mmol/L and HCO3\<18
次要结局
- Acute Kidney Injury(48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization))
- All cause mortality at hospital discharge(Duration of hospital admission)
研究者
Jay Shavadia
Assistant Professor
University of Saskatchewan
研究点 (1)
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