Dapagliflozin effects on cardiovascular events in patients with an acute heart attack - DAPA-MI

Study identifier:D169DC00001

ClinicalTrials.gov identifier:NCT04564742

EudraCT identifier:2020-000664-31

CTIS identifier:N/A

Recruiting

Official Title

A Registry-based, Randomised, 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

Medical condition

Acute Myocardial Infarction

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Placebo

Sex

All

Estimated Enrollment

6400

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Dec 2020

Estimated Primary Completion Date: 14 Jun 2023

Estimated Study Completion Date: 14 Jun 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2023 by AstraZeneca

Collaborators

Uppsala Clinical Research Center

Inclusion and exclusion criteria

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 cell- or 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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Arms	Assigned Interventions
Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo	Drug: Dapagliflozin Dapagliflozin 10 mg tablets given once daily, per oral use Other Name: Forxiga TM Other Name: Farxiga TM
Placebo Comparator: Placebo Placebo matching dapagliflozin	Drug: Placebo Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Stefan James