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DAPA-MI: Dapagliflozin Effects on Cardiovascular Events in Patients With an Acute Heart Attack

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04564742
Collaborator
Uppsala University (Other)
6,400
Enrollment
113
Locations
2
Arms
33
Anticipated Duration (Months)
56.6
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

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 the prevention of hospitalisation for heart failure (HHF) or cardiovascular (CV) death.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a multicentre, parallel group, event-driven, registry-based randomised controlled trial (R-RCT), double-blind, placebo-controlled phase 3 study 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 prevention of hospitalisation for HF or CV death.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Registry-based, Randomised, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Heart Failure or Cardiovascular Death in Patients Without Diabetes With Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure
Actual Study Start Date :
Dec 22, 2020
Anticipated Primary Completion Date :
Sep 22, 2023
Anticipated Study Completion Date :
Sep 22, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF) or cardiovascular (CV) death [From randomization visit (Day 0) up to approximately 3 years]

    Secondary Outcome Measures

    1. Time to the first occurrence of any of the components of this composite: myocardial infarction (MI) or stroke (incl. ischaemic, haemorrhagic and undetermined stroke) or cardiovascular (CV) death [From randomization visit (Day 0) up to approximately 3 years]

    2. Time to the first occurrence of a fatal or a non-fatal MI [From randomization visit (Day 0) up to approximately 3 years]

    3. Time to CV Death [From randomization visit (Day 0) up to approximately 3 years]

    4. Time to death of any cause [From randomization visit (Day 0) up to approximately 3 years]

    5. Time to new onset of type 2 diabetes mellitus (T2DM) post randomisation [From randomization visit (Day 0) up to approximately 3 years]

      New onset of T2DM is defined as: reporting of new onset T2DM necessitating initiation of anti-hyperglycaemic medication or HbA1c ≥ 6.5% (48 mmol/mol) measured by local laboratory at 2 consecutive time points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alingsås Sweden 44183
    2 Research Site Borås Sweden 501 02
    3 Research Site Enköping Sweden 745 25
    4 Research Site Eskilstuna Sweden 631 88
    5 Research Site Falun Sweden 791 82
    6 Research Site Gävle Sweden 801 88
    7 Research Site Göteborg Sweden 413 45
    8 Research Site Göteborg Sweden 416 85
    9 Research Site Halmstad Sweden 30185
    10 Research Site Helsingborg Sweden 251 87
    11 Research Site Hässleholm Sweden 281 25
    12 Research Site Jönköping Sweden 551 85
    13 Research Site Kalix Sweden 952 82
    14 Research Site Karlshamn Sweden 374 80
    15 Research Site Karlskoga Sweden 691 81
    16 Research Site Karlskrona Sweden 371 41
    17 Research Site Karlstad Sweden 651 85
    18 Research Site Kiruna Sweden 981 28
    19 Research Site Köping Sweden 731 81
    20 Research Site Lidköping Sweden 531 85
    21 Research Site Linköping Sweden 581 85
    22 Research Site Luleå Sweden 971 80
    23 Research Site Lund Sweden 222 42
    24 Research Site Malmö Sweden 205 02
    25 Research Site Mölndal Sweden 431 80
    26 Research Site Norrköping Sweden 603 79
    27 Research Site Skellefteå Sweden 931 86
    28 Research Site Sollefteå Sweden 881 04
    29 Research Site Stockholm Sweden 112 81
    30 Research Site Stockholm Sweden 118 83
    31 Research Site Stockholm Sweden 141 86
    32 Research Site Stockholm Sweden 171 76
    33 Research Site Stockholm Sweden 182 88
    34 Research Site Sundsvall Sweden 851 86
    35 Research Site Trollhättan Sweden 461 73
    36 Research Site Umeå Sweden 90737
    37 Research Site Uppsala Sweden 75185
    38 Research Site Varberg Sweden 43281
    39 Research Site Visby Sweden 621 55
    40 Research Site Värnamo Sweden 33185
    41 Research Site Västerås Sweden 723 35
    42 Research Site Ystad Sweden 271 82
    43 Research Site Örebro Sweden 701 85
    44 Research Site Östersund Sweden 831 83
    45 Research Site Aberdeen United Kingdom AB25 2ZN
    46 Research Site Ashford United Kingdom TN24 0LZ
    47 Research Site Basildon United Kingdom SS16 5NL
    48 Research Site Basingstoke United Kingdom RG24 9NA
    49 Research Site Bath United Kingdom BA1 3NG
    50 Research Site Belfast United Kingdom BT12 6BA
    51 Research Site Birmingham United Kingdom B9 5SS
    52 Research Site Blackpool United Kingdom FY3 8NR
    53 Research Site Bournemouth United Kingdom BH7 7DW
    54 Research Site Bradford United Kingdom BD9 6RJ
    55 Research Site Bridgend United Kingdom CF31 1RQ
    56 Research Site Brighton United Kingdom BN2 5BE
    57 Research Site Bristol United Kingdom BS105NB
    58 Research Site Bristol United Kingdom BS2 8HW
    59 Research Site Cambridge United Kingdom CB2 0AY
    60 Research Site Cardiff United Kingdom CF14 4XW
    61 Research Site Clydebank United Kingdom G81 4DY
    62 Research Site Coventry United Kingdom CV2 2DX
    63 Research Site Derby United Kingdom DE22 3NE
    64 Research Site Dundee United Kingdom DD1 9SY
    65 Research Site East Kilbride United Kingdom G75 8RG
    66 Research Site Edgbaston United Kingdom B15 2WB
    67 Research Site Edinburgh United Kingdom EH16 4SA
    68 Research Site Exeter United Kingdom EX2 5DW
    69 Research Site Gillingham United Kingdom ME7 5NY
    70 Research Site Glasgow United Kingdom G4 0SF
    71 Research Site Harefield United Kingdom UB9 6JH
    72 Research Site Harrow United Kingdom HA1 3UJ
    73 Research Site Headington United Kingdom OX3 9DU
    74 Research Site Hull United Kingdom HU16 5JQ
    75 Research Site Kettering United Kingdom NN16 8UZ
    76 Research Site Leeds United Kingdom LS13EX
    77 Research Site Leicester United Kingdom LE3 9QP
    78 Research Site Lincoln United Kingdom LN2 5QY
    79 Research Site Liverpool United Kingdom L14 3PE
    80 Research Site London United Kingdom EC1A 7BE
    81 Research Site London United Kingdom NW3 2QG
    82 Research Site London United Kingdom SE5 9RS
    83 Research Site London United Kingdom SW17 0QT
    84 Research Site London United Kingdom W12 0HS
    85 Research Site Manchester United Kingdom M13 9WL
    86 Research Site Manchester United Kingdom M23 9LT
    87 Research Site Merthyr Tydfil United Kingdom CF47 9DT
    88 Research Site Middlesborough United Kingdom TS4 3BW
    89 Research Site Newcastle upon Tyne United Kingdom NE7 7DN
    90 Research Site Newport United Kingdom NP20 2UB
    91 Research Site Norwich United Kingdom NR4 7UY
    92 Research Site Nottingham United Kingdom NG5 1PB
    93 Research Site Plymouth United Kingdom PL6 8DH
    94 Research Site Pontyclun United Kingdom CF72 8XR
    95 Research Site Portsmouth United Kingdom PO6 3LY
    96 Research Site Rhyl United Kingdom LL18 5UJ
    97 Research Site Scarborough United Kingdom YO12 6QL
    98 Research Site Sheffield United Kingdom S5 7AU
    99 Research Site Southampton United Kingdom SO166YD
    100 Research Site Stevenage United Kingdom SG1 4AB
    101 Research Site Stoke on Trent United Kingdom ST4 6QG
    102 Research Site Sunderland United Kingdom SR4 7TP
    103 Research Site Swansea United Kingdom SA6 6NL
    104 Research Site Taunton United Kingdom TA1 5DA
    105 Research Site Torquay United Kingdom TQ2 7AA
    106 Research Site Truro United Kingdom TR1 3LJ
    107 Research Site Wakefield United Kingdom WF1 4DG
    108 Research Site West Bromwich United Kingdom B71 4HJ
    109 Research Site Wigan United Kingdom WN1 2NN
    110 Research Site Wolverhampton United Kingdom WV10 0QP
    111 Research Site Worcester United Kingdom WR5 1DD
    112 Research Site Worthing United Kingdom BN11 2DH
    113 Research Site York United Kingdom YO31 8HE

    Sponsors and Collaborators

    • AstraZeneca
    • Uppsala University

    Investigators

    • Principal Investigator: Stefan James, Uppsala University
    • Study Chair: Jonas Oldgren, Uppsala University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04564742
    Other Study ID Numbers:
    • D169DC00001
    • 2020-000664-31
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AstraZeneca
    Myocardial Infarction
    Cardiovascular Outcome Trial
    Additional relevant MeSH terms:
    Heart Failure
    Myocardial Infarction
    Infarction
    Dapagliflozin

    Study Results

    No Results Posted as of Aug 19, 2022