Dapagliflozin Effects on Cardiovascular Events in Patients With an Acute Heart Attack (DAPA-MI)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2023
  • participants needed
    6400
  • sponsor
    AstraZeneca
Updated on 3 July 2022
ejection fraction
heart failure
myocardial infarction
infarct
MRI
cardiac mri
ventriculogram

Summary

This study will evaluate the effect of dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI), for the prevention of hospitalisation for heart failure (HHF) or cardiovascular (CV) death.

Description

This is a multicentre, parallel group, event-driven, registry-based randomised controlled trial (R-RCT), double-blind, placebo-controlled phase 3 study in patients without diabetes presenting with myocardial infarction (MI) (ST segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI)) and evidence of impaired regional or global LV systolic function or definite evidence of Q wave MI on ECG. In the study the effect of dapagliflozin versus placebo, given once daily in addition to SoC therapy will be evaluated for the prevention of hospitalisation for HF or CV death.

Details
Condition Acute Myocardial Infarction, Heart Failure
Treatment Placebo, Dapagliflozin
Clinical Study IdentifierNCT04564742
SponsorAstraZeneca
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be ≥18 at the time of signing the informed consent
Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019), within the preceding 7 days, or 10 days if earlier randomisation is not feasible
Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation (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)
Hemodynamically stable at randomization (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours)
Male or female
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses

Exclusion Criteria

Known type 1 diabetes mellitus (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. Patients who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise and shortness of breath should be assessed for ketoacidosis, and if ketoacidosis is confirmed the patient should not be randomized
Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization
Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial
Active malignancy requiring treatment at the time of screening, except for basal cellor squamous cell carcinoma of the skin, presumed possible to treat successfully
Any non-CV condition, eg malignancy, with a life expectancy of less than two years based on the investigator´s clinical judgement
Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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