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Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack. (DAPA-MI)

Primary Purpose

Acute Myocardial Infarction, Heart Failure

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dapagliflozin

Placebo

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial Infarction, Cardiovascular Outcome Trial

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Placebo

Arm Description

Patients will be randomized 1:1 to either dapagliflozin or placebo

Placebo matching dapagliflozin

Outcomes

Primary Outcome Measures

The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hosp due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, last visit NYHA class, and weight loss ≥5%

Secondary Outcome Measures

The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hospitalisation due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, and last visit NYHA class

Time to the first occurrence of any of the components of this composite: • HHF • CV death

Time to the first occurrence of any of the components of this composite: • MI • Stroke (incl. ischaemic, haemorrhagic and undetermined stroke) • CV death

Time to CV death

Time to the first occurrence of a fatal or a non-fatal MI

Time to new onset of T2DM

Change from baseline in Body weight

Time to hospitalisation for any cause

Time to death of any cause

Full Information

NCT ID

NCT04564742

First Posted

September 3, 2020

Last Updated

August 3, 2023

Sponsor

AstraZeneca

Collaborators

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT04564742

Brief Title

Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.

Acronym

DAPA-MI

Official Title

A Registry-based, Randomised, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on Cardiometabolic Outcomes in Patients Without Diabetes With Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 22, 2020 (Actual)

Primary Completion Date

July 5, 2023 (Actual)

Study Completion Date

July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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 hospitalisation for heart failure (HHF), cardiovascular (CV) death, and other cardiometabolic outcomes.

Detailed Description

This is a multicentre, parallel group double-blind, placebo-controlled phase 3 registry-based randomised controlled trial (R-RCT) 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 hospitalisation for HF, CV death, and other cardiometabolic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction, Heart Failure

Keywords

Myocardial Infarction, Cardiovascular Outcome Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4017 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapagliflozin

Arm Type

Experimental

Arm Description

Patients will be randomized 1:1 to either dapagliflozin or placebo

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo matching dapagliflozin

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Other Intervention Name(s)

Forxiga TM, Farxiga TM

Intervention Description

Dapagliflozin 10 mg tablets given once daily, per oral use

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use

Primary Outcome Measure Information:

Title

Time Frame