A Registry-based, Randomized, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Heart Failure or Cardiovascular Death in Patients without Diabetes with Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure - DAPA-MI

Astra Zeneca AB0 个研究点目标入组 6,400 人开始时间: 2020年7月24日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1. Participant must be =18 at the time of signing the informed consent.
•2 Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019), within the preceding 7 days
•3. Evidence of reduced LVEF during current MI-related hospitalization (LVEF<50%), established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI or definitive evidence on ECG of Q wave MI (defined as presence of Q waves in two or more contiguous leads, excluding leads III and aVR, and meeting all the following criteria: at least 1.5 mm in depth; at least 30 ms in duration; and, if R wave present, more than 25% of the size of the subsequent R wave).
•4. Hemodynamically stable at randomization (no episodes of symptomatic hypotension, systolic blood pressure < 95 mmHg or arrhythmia with haemodynamic compromise in the last 24 hours).
•5. Male or female
•6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
•7. Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses.
•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 1920
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4480

•1. Known T1DM or T2DM at the time for admission. Patients with hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the index event, are eligible at the discretion of the Investigator.
•2. Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF=40 %), documented before the current MI hospitalization.
•3. Severe (eGFR <20 mL/min/1.73 m2) by local laboratory unstable or rapidly progressing renal disease at the time of randomization.
•4. Severe hepatic impairment (Child-Pugh class C) at the time for in the trial.
•5. Active malignancy requiring treatment at the time of screening, except for basal cell- or squamous cell carcinoma of the skin, presumed possible to treat successfully.
•6. Any non-CV condition, eg malignancy, with a life expectancy of less than two years based on the investigator´s clinical judgement.
•7. Currently on treatment, or with an indication for treatment, with a SGLT2-inhibitor.

发起方

Astra Zeneca AB