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Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack. (DAPA-MI)

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ClinicalTrials.gov Identifier: NCT04564742

Recruitment Status : Completed

First Posted : September 25, 2020

Last Update Posted : August 4, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Uppsala University

Information provided by (Responsible Party):

AstraZeneca

Tracking Information

First Submitted Date ^ICMJE

September 3, 2020

First Posted Date ^ICMJE

September 25, 2020

Last Update Posted Date

August 4, 2023

Actual Study Start Date ^ICMJE

December 22, 2020

Actual Primary Completion Date

July 5, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hosp due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, last visit NYHA class, and weight loss ≥5% [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Current Secondary Outcome Measures ^ICMJE

The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hospitalisation due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, and last visit NYHA class [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to the first occurrence of any of the components of this composite: • HHF • CV death [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to the first occurrence of any of the components of this composite: • MI • Stroke (incl. ischaemic, haemorrhagic and undetermined stroke) • CV death [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to CV death [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to the first occurrence of a fatal or a non-fatal MI [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to new onset of T2DM [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Change from baseline in Body weight [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to hospitalisation for any cause [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]
Time to death of any cause [ Time Frame: From randomization visit up to approximately 30 months, with a minimum follow-up time of at least 3 months for each patient ]

Original Secondary Outcome Measures ^ICMJE

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 ]
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 ]
Time to CV Death [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
Time to death of any cause [ Time Frame: From randomization visit (Day 0) up to approximately 3 years ]
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

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction
Heart Failure

Intervention ^ICMJE

Drug: Dapagliflozin
Dapagliflozin 10 mg tablets given once daily, per oral use
Other Names:
- Forxiga TM
- Farxiga TM
Drug: Placebo
Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use

Study Arms ^ICMJE

Experimental: Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo

Intervention: Drug: Dapagliflozin
Placebo Comparator: Placebo
Placebo matching dapagliflozin

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

4017

Original Estimated Enrollment ^ICMJE

6400

Actual Study Completion Date ^ICMJE

July 5, 2023

Actual Primary Completion Date

July 5, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 130 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Sweden, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04564742

Other Study ID Numbers ^ICMJE

D169DC00001
2020-000664-31 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

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 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.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (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.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home