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

Last updated: February 17, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Heart Failure

Congestive Heart Failure

Heart Defect

Treatment

Placebo

Dapagliflozin

Clinical Study ID

NCT04564742
D169DC00001
2020-000664-31
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 definitionof MI (Thygesen et al 2019), within the preceding 7 days, or 10 days if earlierrandomisation is not feasible

  • Evidence of impaired regional or global LV systolic function at any timepoint duringcurrent MI-related hospitalisation (established with echocardiogram, radionuclideventriculogram, contrast angiography or cardiac MRI) or definitive evidence on ECGof 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 mmin depth; at least 30 ms in duration; and, if R wave present, more than 25% of thesize of the subsequent R wave)

  • Hemodynamically stable at randomization (no episodes of symptomatic hypotension, orarrhythmia with haemodynamic compromise in the last 24 hours).

  • Male or female

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in theprotocol

  • Provision of signed and dated, written informed consent prior to any mandatory studyspecific procedures, sampling, and analyses

Exclusion

Exclusion Criteria:

  • Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission. Patientswith hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the indexevent, are eligible at the discretion of the Investigator. Patients who present withsigns 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 reducedejection fraction (LVEF≤40 %), documented before the current MI hospitalization

  • Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidlyprogressing renal disease at the time of randomization

  • Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into thetrial

  • Active malignancy requiring treatment at the time of screening, except for basalcell- or squamous cell carcinoma of the skin, presumed possible to treatsuccessfully

  • Any non-CV condition, eg malignancy, with a life expectancy of less than two yearsbased on the investigator´s clinical judgement

  • Currently on treatment, or with an indication for treatment, with a sodium glucoseco-transporter 2 inhibitor (SGLT2-inhibitor)

Study Design

Total Participants: 4017
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 22, 2020
Estimated Completion Date:
July 05, 2023

Study 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.

Connect with a study center

  • Research Site

    Alingsås, 44183
    Sweden

    Site Not Available

  • Research Site

    Borås, 501 02
    Sweden

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  • Research Site

    Enköping, 745 25
    Sweden

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  • Research Site

    Eskilstuna, 631 88
    Sweden

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  • Research Site

    Falun, 791 82
    Sweden

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  • Research Site

    Gävle, 801 88
    Sweden

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  • Research Site

    Göteborg, 416 85
    Sweden

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  • Research Site

    Halmstad, 30185
    Sweden

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  • Research Site

    Helsingborg, 251 87
    Sweden

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  • Research Site

    Hässleholm, 281 25
    Sweden

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  • Research Site

    Jönköping, 551 85
    Sweden

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  • Research Site

    Kalix, 952 82
    Sweden

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  • Research Site

    Karlshamn, 374 80
    Sweden

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  • Research Site

    Karlskoga, 691 81
    Sweden

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  • Research Site

    Karlskrona, 371 41
    Sweden

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    Karlstad, 651 85
    Sweden

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  • Research Site

    Kiruna, 981 28
    Sweden

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  • Research Site

    Köping, 731 81
    Sweden

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  • Research Site

    Lidköping, 531 85
    Sweden

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  • Research Site

    Linköping, 581 85
    Sweden

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  • Research Site

    Luleå, 971 80
    Sweden

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  • Research Site

    Lund, 222 42
    Sweden

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  • Research Site

    Malmö, 205 02
    Sweden

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  • Research Site

    Mölndal, 431 80
    Sweden

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  • Research Site

    Norrköping, 603 79
    Sweden

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    Skellefteå, 931 86
    Sweden

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    Sollefteå, 881 04
    Sweden

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    Stockholm, 118 83
    Sweden

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    Sundsvall, 851 86
    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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  • Research Site

    Visby, 621 55
    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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    Örebro, 701 85
    Sweden

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    Östersund, 831 83
    Sweden

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    Aberdeen, AB25 2ZN
    United Kingdom

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    Ashford, TN24 0LZ
    United Kingdom

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    Basildon, SS16 5NL
    United Kingdom

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    Basingstoke, RG24 9NA
    United Kingdom

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    Bath, BA1 3NG
    United Kingdom

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    Belfast, BT12 6BA
    United Kingdom

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    Birmingham, B9 5SS
    United Kingdom

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    Blackburn, BB2 3HH
    United Kingdom

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    Blackpool, FY3 8NR
    United Kingdom

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    Bournemouth, BH7 7DW
    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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    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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    Dartford, DA2 8DA
    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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    Halifax, HX3 0PW
    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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    Kent, ME7 5NY
    United Kingdom

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    Kettering, NN16 8UZ
    United Kingdom

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  • Research Site

    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, SE5 9RS
    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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    Middlesborough, 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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    Pontyclun, 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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    West Bromwich, B71 4HJ
    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

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  • Research Site

    York, YO31 8HE
    United Kingdom

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