Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Mayor adverse cardiovascular effects
研究概览
简要总结
The actual evidence is solid about the use of de SGLT2-inhibitors in wide spectrum of cardiorenal targets, which has been shown in a great amount of randomized clinical trials compared with placebo. At present it must be taken into account as first line treatment in patients with DM2, even their security profile has allowed the use in patients without diagnosis of DM2, since they have be shown a beneficial cardioprotect effects. Most studies support they use in patients with high cardiovascular risk, nevertheless, their use in patients with recent diagnosis of ischemic hearth disease its limited, being the latter entity the most frequent etiology found in patients who develop chronic hearth failure either as part of heart attack or unstable angina.
详细描述
According with the World Health Organization, cardiovascular disease is the leading cause of mortality in the world, estimating 17.9 millions of deaths a year. The cardiovascular disease are a group of disorders of the hearth and the blood vessels including coronary artery disease, cerebrovascular disease, rheumatic hearth disease and other conditions. Four out of five deaths attributed to cardiovascular cause are related to acute myocardial infarction and cerebrovascular disease and one third of this deaths occur in persons younger than 70 years.
The concept of acute coronary syndrome includes the ST elevation myocardial infarction who presents a ST elevation in two contiguous leads or complete left branch bundle block instead patients who presents without ST elevation in the electrocardiogram they are usually classified as Non ST elevation acute myocardial infarction.
The optimum treatment of the STEMI must be based in the utilization of networks between hospitals with different technology levels connected by an efficient y prioritized ambulance system. The objective of this networks is to provide an efficient medical attention, reduce the lag time and to get better the clinical results. The percutaneous coronary intervention is the preferred treatment of reperfusion for the patients with acute myocardial infarction on the first 12 hours after the development of symptoms, provided it can be done quickly (120 minutes since the diagnosis). In some circumstances, the PCI is not an option, then the fibrinolysis could be started immediately.
Most patients with ischemic heart disease are carriers of DM2. The DM2 is associated to an increase 3 times the risk of cardiovascular disease being this the principal cause of morbidity and mortality in this patients. Further, more than 40% of the patient with DM2 develops diabetic nephropathy and this increase strongly the risk of poor cardiovascular outcomes.
Improve the glycemic control in patients with DM2 has been a major objective in the clinical practice for decades, abreast to a reduction of the multifactorial cardiovascular risk. On randomized trials, controlled with placebo, the sodium-glucose linked transported inhibitors type 2 have shown convincingly improve the cardiovascular results, including a reduction in cardiovascular death and particularly, the reduction in the occurrence of heart failure leading to hospitalization . The consistent evidence of the beneficial cardiovascular effects of SGLT-2 inhibitors has led to recommend it in international papers for patients with DM2 and cardiovascular disease in addition to metformin, regardless of their basal levels of glycated hemoglobin.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female IMSS eligible patients over 18 years of age
- •Meet the criteria of the fourth definition of ST-segment elevation myocardial infarction
- •Known with diabetes mellitus 2 or newly diagnosed diabetes according to ADA criteria
排除标准
- •Patients diagnosed with Type 1 Diabetes Mellitus
- •Patients on chronic replacement therapy for renal function through peritoneal dialysis or hemodialysis
- •Patients who have recently undergone immunosuppressive therapy
- •Patients with a history of recurrent urinary tract infection
- •Patients known to be allergic to SGLT-2 inhibitors
- •Patients presenting as sudden aborted death
- •Patients who after percutaneous coronary intervention require orotracheal intubation
研究组 & 干预措施
Intervention Group
Dapagliflozin 10 mg every 24 hours for 12 months
干预措施: Dapagliflozin 10Mg Tab (Drug)
Control Group
1 placebo tablet every 24 hours for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Mayor adverse cardiovascular effects
时间窗: 12 months
To assess the presence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the study follow-up
次要结局
- Left ventricular ejection fraction(12 months)
- Mortality due to cardiovascular cause(12 months)
- Chronic heart failure(12 months)
- Post infarction angina(12 months)
研究者
Hilda Elizabeth Macías Cervantes
Internist Physician and Master in Clinical Research assigned to the Internal Medicine Service, High Specialty Medical Unit No. 1, Bajío, Leon, Guanajuato
Instituto Mexicano del Seguro Social
