Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
DAPA-MI
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
2 other identifiers
interventional
4,017
2 countries
103
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Typical duration for phase_3
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedResults Posted
Study results publicly available
March 7, 2025
CompletedMarch 7, 2025
February 1, 2025
2.5 years
September 3, 2020
July 2, 2024
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
29 months
Study Arms (2)
Dapagliflozin
EXPERIMENTALPatients will be randomized 1:1 to either dapagliflozin or placebo
Placebo
PLACEBO COMPARATORPlacebo matching dapagliflozin
Interventions
Dapagliflozin 10 mg tablets given once daily, per oral use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Uppsala Universitycollaborator
Study Sites (103)
Research Site
Alingsås, 44183, Sweden
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Borås, 501 02, Sweden
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Eskilstuna, 631 88, Sweden
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Falun, 791 82, Sweden
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Gävle, 801 88, Sweden
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Gothenburg, 413 45, Sweden
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Gothenburg, 416 85, Sweden
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Halmstad, 30185, Sweden
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Hässleholm, 281 25, Sweden
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Helsingborg, 251 87, Sweden
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Jönköping, 551 85, Sweden
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Kalix, 952 82, Sweden
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Karlshamn, 374 80, Sweden
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Karlskoga, 691 81, Sweden
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Karlskrona, 371 41, Sweden
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Karlstad, 651 85, Sweden
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Kiruna, 981 28, Sweden
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Köping, 731 81, Sweden
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Lidköping, 531 85, Sweden
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Linköping, 581 85, Sweden
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Lund, 222 42, Sweden
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Malmo, 205 02, Sweden
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Mölndal, 431 80, Sweden
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Norrköping, 603 79, Sweden
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Örebro, 701 85, Sweden
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Östersund, 831 83, Sweden
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Skellefteå, 931 86, Sweden
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Stockholm, 112 81, Sweden
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Stockholm, 118 83, Sweden
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Stockholm, 141 86, Sweden
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Stockholm, 171 76, Sweden
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Stockholm, 182 88, Sweden
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Trollhättan, 461 73, Sweden
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Umeå, 90737, Sweden
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Uppsala, 75185, Sweden
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Varberg, 43281, Sweden
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Värnamo, 33185, Sweden
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Västerås, 723 35, Sweden
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Ystad, 271 82, Sweden
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Aberdeen, AB25 2ZN, United Kingdom
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Ashford, TN24 0LZ, United Kingdom
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Basingstoke, RG24 9NA, United Kingdom
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Bath, BA1 3NG, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Bridgend, CF31 1RQ, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Bristol, BS105NB, United Kingdom
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Bristol, BS2 8HW, United Kingdom
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Buckhurst Hill, IG9 5HX, United Kingdom
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Cambridge, CB2 0AY, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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Clydebank, G81 4DY, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Derby, DE22 3NE, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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East Kilbride, G75 8RG, United Kingdom
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Edgbaston, B15 2WB, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Gillingham, ME7 5NY, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Harefield, UB9 6JH, United Kingdom
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Harrow, HA1 3UJ, United Kingdom
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Headington, OX3 9DU, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Kettering, NN16 8UZ, United Kingdom
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Leeds, LS13EX, United Kingdom
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Leicester, LE3 9QP, United Kingdom
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Lincoln, LN2 5QY, United Kingdom
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Liverpool, L14 3PE, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE5 9RS, United Kingdom
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London, SW17 0QT, United Kingdom
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London, W12 0HS, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Merthyr Tydfil, CF47 9DT, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Newport, NP20 2UB, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Pont-y-clun, CF72 8XR, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Rhyl, LL18 5UJ, United Kingdom
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Scarborough, YO12 6QL, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Southampton, SO166YD, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
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Sunderland, SR4 7TP, United Kingdom
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Swansea, SA6 6NL, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Wigan, WN1 2NN, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
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Worcester, WR5 1DD, United Kingdom
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Worthing, BN11 2DH, United Kingdom
Related Publications (2)
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.
PMID: 38320489DERIVEDJames 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.
PMID: 37648579DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan James
Uppsala University
- STUDY CHAIR
Jonas Oldgren
Uppsala University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 25, 2020
Study Start
December 22, 2020
Primary Completion
July 5, 2023
Study Completion
July 5, 2023
Last Updated
March 7, 2025
Results First Posted
March 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.