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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564742
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
AstraZeneca

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
Acute Myocardial Infarction Heart Failure Drug: Dapagliflozin Drug: Placebo 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 a reduced left ventricular ejection fraction (LVEF); defined as LVEF < 50% 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 21, 2020
Estimated Primary Completion Date : June 22, 2023
Estimated Study Completion Date : June 22, 2023

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: 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 [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
  2. Time to the first occurrence of a fatal or a non-fatal MI [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
  3. Time to CV Death [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
  4. Time to death of any cause [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
  5. Time to new onset of type 2 diabetes mellitus (T2DM) post randomisation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Evidence of reduced left ventricular ejection fraction (LVEF) during current MI-related hospitalization (LVEF<50%), 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, systolic blood pressure < 95 mmHg 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
  • 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 for in 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564742


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United Kingdom
Research Site
Basildon, United Kingdom, SS16 5NL
Research Site
Blackpool, United Kingdom, FY3 8NR
Research Site
Bradford, United Kingdom, BD9 6RJ
Research Site
Hull, United Kingdom, HU16 5JQ
Research Site
Leicester, United Kingdom, LE3 9QP
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Research Site
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
AstraZeneca
Uppsala University
Investigators
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Principal Investigator: Stefan James Uppsala University
Study Chair: Jonas Oldgren Uppsala University
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04564742    
Other Study ID Numbers: D169DC00001
2020-000664-31 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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. All request 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 shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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:
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Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs