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

February 17, 2025 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4017

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsås, Sweden, 44183
        • Research Site
      • Borås, Sweden, 501 02
        • Research Site
      • Eskilstuna, Sweden, 631 88
        • Research Site
      • Falun, Sweden, 791 82
        • Research Site
      • Gävle, Sweden, 801 88
        • Research Site
      • Göteborg, Sweden, 413 45
        • Research Site
      • Göteborg, Sweden, 416 85
        • Research Site
      • Halmstad, Sweden, 30185
        • Research Site
      • Helsingborg, Sweden, 251 87
        • Research Site
      • Hässleholm, Sweden, 281 25
        • Research Site
      • Jönköping, Sweden, 551 85
        • Research Site
      • Kalix, Sweden, 952 82
        • Research Site
      • Karlshamn, Sweden, 374 80
        • Research Site
      • Karlskoga, Sweden, 691 81
        • Research Site
      • Karlskrona, Sweden, 371 41
        • Research Site
      • Karlstad, Sweden, 651 85
        • Research Site
      • Kiruna, Sweden, 981 28
        • Research Site
      • Köping, Sweden, 731 81
        • Research Site
      • Lidköping, Sweden, 531 85
        • Research Site
      • Linköping, Sweden, 581 85
        • Research Site
      • Lund, Sweden, 222 42
        • Research Site
      • Malmö, Sweden, 205 02
        • Research Site
      • Mölndal, Sweden, 431 80
        • Research Site
      • Norrköping, Sweden, 603 79
        • Research Site
      • Skellefteå, Sweden, 931 86
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Stockholm, Sweden, 118 83
        • Research Site
      • Stockholm, Sweden, 171 76
        • Research Site
      • Stockholm, Sweden, 182 88
        • Research Site
      • Stockholm, Sweden, 112 81
        • Research Site
      • Trollhättan, Sweden, 461 73
        • Research Site
      • Umeå, Sweden, 90737
        • Research Site
      • Uppsala, Sweden, 75185
        • Research Site
      • Varberg, Sweden, 43281
        • Research Site
      • Värnamo, Sweden, 33185
        • Research Site
      • Västerås, Sweden, 723 35
        • Research Site
      • Ystad, Sweden, 271 82
        • Research Site
      • Örebro, Sweden, 701 85
        • Research Site
      • Östersund, Sweden, 831 83
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Research Site
      • Ashford, United Kingdom, TN24 0LZ
        • Research Site
      • Basingstoke, United Kingdom, RG24 9NA
        • Research Site
      • Bath, United Kingdom, BA1 3NG
        • Research Site
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Blackpool, United Kingdom, FY3 8NR
        • Research Site
      • Bradford, United Kingdom, BD9 6RJ
        • Research Site
      • Bridgend, United Kingdom, CF31 1RQ
        • Research Site
      • Brighton, United Kingdom, BN2 5BE
        • Research Site
      • Bristol, United Kingdom, BS105NB
        • Research Site
      • Bristol, United Kingdom, BS2 8HW
        • Research Site
      • Buckhurst Hill, United Kingdom, IG9 5HX
        • Research Site
      • Cambridge, United Kingdom, CB2 0AY
        • Research Site
      • Cardiff, United Kingdom, CF14 4XW
        • Research Site
      • Clydebank, United Kingdom, G81 4DY
        • Research Site
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • Derby, United Kingdom, DE22 3NE
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • East Kilbride, United Kingdom, G75 8RG
        • Research Site
      • Edgbaston, United Kingdom, B15 2WB
        • Research Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Research Site
      • Exeter, United Kingdom, EX2 5DW
        • Research Site
      • Gillingham, United Kingdom, ME7 5NY
        • Research Site
      • Glasgow, United Kingdom, G4 0SF
        • Research Site
      • Harefield, United Kingdom, UB9 6JH
        • Research Site
      • Harrow, United Kingdom, HA1 3UJ
        • Research Site
      • Headington, United Kingdom, OX3 9DU
        • Research Site
      • Hull, United Kingdom, HU16 5JQ
        • Research Site
      • Kettering, United Kingdom, NN16 8UZ
        • Research Site
      • Leeds, United Kingdom, LS13EX
        • Research Site
      • Leicester, United Kingdom, LE3 9QP
        • Research Site
      • Lincoln, United Kingdom, LN2 5QY
        • Research Site
      • Liverpool, United Kingdom, L14 3PE
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • London, United Kingdom, SW17 0QT
        • Research Site
      • London, United Kingdom, W12 0HS
        • Research Site
      • Manchester, United Kingdom, M13 9WL
        • Research Site
      • Manchester, United Kingdom, M23 9LT
        • Research Site
      • Merthyr Tydfil, United Kingdom, CF47 9DT
        • Research Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Research Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Newport, United Kingdom, NP20 2UB
        • Research Site
      • Norwich, United Kingdom, NR4 7UY
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Plymouth, United Kingdom, PL6 8DH
        • Research Site
      • Pontyclun, United Kingdom, CF72 8XR
        • Research Site
      • Portsmouth, United Kingdom, PO6 3LY
        • Research Site
      • Rhyl, United Kingdom, LL18 5UJ
        • Research Site
      • Scarborough, United Kingdom, YO12 6QL
        • Research Site
      • Sheffield, United Kingdom, S5 7AU
        • Research Site
      • Southampton, United Kingdom, SO166YD
        • Research Site
      • Stevenage, United Kingdom, SG1 4AB
        • Research Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Research Site
      • Sunderland, United Kingdom, SR4 7TP
        • Research Site
      • Swansea, United Kingdom, SA6 6NL
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
        • Research Site
      • Torquay, United Kingdom, TQ2 7AA
        • Research Site
      • Truro, United Kingdom, TR1 3LJ
        • Research Site
      • Wakefield, United Kingdom, WF1 4DG
        • Research Site
      • Wigan, United Kingdom, WN1 2NN
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
      • Worcester, United Kingdom, WR5 1DD
        • Research Site
      • Worthing, United Kingdom, BN11 2DH
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Forxiga TM
  • Farxiga TM
Placebo Comparator: Placebo
Placebo matching dapagliflozin
Drug: Placebo
Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)
Time Frame: 29 months

Study participants received dapagliflozin 10 mg or matching placebo, given once daily in addition to SoC. Overall, the mean study duration was 12.0 months (time in study until last visit) with an accumulated 4023.9 participant-years. The maximum study duration for any participant was 29 months.

"Number of Events" for NYHA corresponds to the number of participants with a non-missing value for NYHA functional class at the last visit, and that all participants with a non-missing value take part in the analysis comparing their NYHA class value with all other participants with a NYHA value, according to the win-ratio method.
29 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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 Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to the first occurrence of any of the components of this composite: • HHF • CV death
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to the first occurrence of any of the components of this composite: • MI • Stroke (incl. ischaemic, haemorrhagic and undetermined stroke) • CV death
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to CV death
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to the first occurrence of a fatal or a non-fatal MI
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to new onset of T2DM
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Change from baseline in Body weight
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to hospitalisation for any cause
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
Time to death of any cause
Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient
From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan James, Uppsala University
  • Study Chair: Jonas Oldgren, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D169DC00001
  • 2020-000664-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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