Acute Myocardial InfarctionPhase 3DAPA-MINCT04564742
Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
A Phase 3 study testing Dapagliflozin in people with Acute Myocardial Infarction and Heart Failure, run by AstraZeneca at 103 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,017 participants
- Where
- 103 sitesin 2 countries
- Study dates
- 22 Dec 2020to 5 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
103 sites in 2 countries.
103 sites in 2 countries
United Kingdom64 sites
Research Site
Aberdeen, AB25 2ZN
Research Site
Ashford, TN24 0LZ
Research Site
Basingstoke, RG24 9NA
Research Site
Bath, BA1 3NG
Research Site
Birmingham, B9 5SS
Research Site
Blackpool, FY3 8NR
Research Site
Bradford, BD9 6RJ
Research Site
Bridgend, CF31 1RQ
Research Site
Brighton, BN2 5BE
Research Site
Bristol, BS105NB
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Bristol, BS2 8HW
Research Site
Buckhurst Hill, IG9 5HX
Research Site
Cambridge, CB2 0AY
Research Site
Cardiff, CF14 4XW
Research Site
Clydebank, G81 4DY
Research Site
Coventry, CV2 2DX
Research Site
Derby, DE22 3NE
Research Site
Dundee, DD1 9SY
Research Site
East Kilbride, G75 8RG
Research Site
Edgbaston, B15 2WB
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Edinburgh, EH16 4SA
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Exeter, EX2 5DW
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Gillingham, ME7 5NY
Research Site
Glasgow, G4 0SF
Research Site
Harefield, UB9 6JH
Research Site
Harrow, HA1 3UJ
Research Site
Headington, OX3 9DU
Research Site
Hull, HU16 5JQ
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Kettering, NN16 8UZ
Research Site
Leeds, LS13EX
Research Site
Leicester, LE3 9QP
Research Site
Lincoln, LN2 5QY
Research Site
Liverpool, L14 3PE
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London, NW3 2QG
Research Site
London, SE5 9RS
Research Site
London, SW17 0QT
Research Site
London, W12 0HS
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Manchester, M13 9WL
Research Site
Manchester, M23 9LT
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Merthyr Tydfil, CF47 9DT
Research Site
Middlesbrough, TS4 3BW
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Newport, NP20 2UB
Research Site
Norwich, NR4 7UY
Research Site
Nottingham, NG5 1PB
Research Site
Plymouth, PL6 8DH
Research Site
Pont-y-clun, CF72 8XR
Research Site
Portsmouth, PO6 3LY
Research Site
Rhyl, LL18 5UJ
Research Site
Scarborough, YO12 6QL
Research Site
Sheffield, S5 7AU
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Southampton, SO166YD
Research Site
Stevenage, SG1 4AB
Research Site
Stoke-on-Trent, ST4 6QG
Research Site
Sunderland, SR4 7TP
Research Site
Swansea, SA6 6NL
Research Site
Taunton, TA1 5DA
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Torquay, TQ2 7AA
Research Site
Truro, TR1 3LJ
Research Site
Wakefield, WF1 4DG
Research Site
Wigan, WN1 2NN
Research Site
Wolverhampton, WV10 0QP
Research Site
Worcester, WR5 1DD
Research Site
Worthing, BN11 2DH
Sweden39 sites
Research Site
Alingsås, 44183
Research Site
Borås, 501 02
Research Site
Eskilstuna, 631 88
Research Site
Falun, 791 82
Research Site
Gävle, 801 88
Research Site
Gothenburg, 413 45
Research Site
Gothenburg, 416 85
Research Site
Halmstad, 30185
Research Site
Hässleholm, 281 25
Research Site
Helsingborg, 251 87
Research Site
Jönköping, 551 85
Research Site
Kalix, 952 82
Research Site
Karlshamn, 374 80
Research Site
Karlskoga, 691 81
Research Site
Karlskrona, 371 41
Research Site
Karlstad, 651 85
Research Site
Kiruna, 981 28
Research Site
Köping, 731 81
Research Site
Lidköping, 531 85
Research Site
Linköping, 581 85
Research Site
Lund, 222 42
Research Site
Malmö, 205 02
Research Site
Mölndal, 431 80
Research Site
Norrköping, 603 79
Research Site
Örebro, 701 85
Research Site
Östersund, 831 83
Research Site
Skellefteå, 931 86
Research Site
Stockholm, 112 81
Research Site
Stockholm, 118 83
Research Site
Stockholm, 141 86
Research Site
Stockholm, 171 76
Research Site
Stockholm, 182 88
Research Site
Trollhättan, 461 73
Research Site
Umeå, 90737
Research Site
Uppsala, 75185
Research Site
Varberg, 43281
Research Site
Värnamo, 33185
Research Site
Västerås, 723 35
Research Site
Ystad, 271 82
About this study
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
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Myocardial Infarction, Cardiovascular Outcome Trial
- Medical subject headings
- Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga TM, Farxiga TM
Dapagliflozin 10 mg tablets given once daily, per oral use
PlaceboDrug
Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Patients will be randomized 1:1 to either dapagliflozin or placebo Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo matching dapagliflozin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)
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.
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 Dec 2020
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Stefan James, Principal investigator, Uppsala UniversityJonas Oldgren, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564742
- Sponsor's protocol ID
- D169DC00001
- Other IDs
- 2020-000664-31
- Acronym
- DAPA-MI
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2020
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.
PubMed 38320489James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Bjorkgren I, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction. Am Heart J. 2023 Dec;266:188-197. doi: 10.1016/j.ahj.2023.08.008. Epub 2023 Aug 28.
PubMed 37648579
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04564742
- Acronym / sponsor ID
- DAPA-MI / D169DC00001
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Myocardial Infarction, Cardiovascular Outcome Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,017 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinPatients will be randomized 1:1 to either dapagliflozin or placebo |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching dapagliflozin |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: Forxiga TM, Farxiga TMDapagliflozin 10 mg tablets given once daily, per oral use | Drug | Dapagliflozin |
| PlaceboPlacebo matching dapagliflozin 10 mg tablets given once daily, per oral use | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38320489James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.
- Derived from this study: PubMed 37648579James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Bjorkgren I, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction. Am Heart J. 2023 Dec;266:188-197. doi: 10.1016/j.ahj.2023.08.008. Epub 2023 Aug 28.
- CSP redactedLink provided by the sponsor.
- SAP redactedLink provided by the sponsor.
- CSR Synopsis redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan James principal investigator
Uppsala University
Jonas Oldgren study chair
Uppsala University
103 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin in people with Acute Myocardial Infarction and Heart Failure, run by AstraZeneca at 103 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set) (time frame: 29 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.