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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04509674




Registration number
NCT04509674
Ethics application status
Date submitted
10/08/2020
Date registered
12/08/2020

Titles & IDs
Public title
EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)
Scientific title
EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction
Secondary ID [1] 0 0
2019-001037-13
Secondary ID [2] 0 0
1245-0202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo

Experimental: Empagliflozin -

Placebo comparator: Placebo -


Treatment: Drugs: Empagliflozin
Empagliflozin

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of time to first heart failure hospitalisation or all-cause mortality
Timepoint [1] 0 0
up to 26 months
Secondary outcome [1] 0 0
Total number of HHF or all-cause mortality
Timepoint [1] 0 0
up to 26 months
Secondary outcome [2] 0 0
Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality
Timepoint [2] 0 0
up to 26 months
Secondary outcome [3] 0 0
Total number of non-elective all-cause hospitalisations or all-cause mortality
Timepoint [3] 0 0
up to 26 months
Secondary outcome [4] 0 0
Total number of hospitalisations for MI or all-cause mortality
Timepoint [4] 0 0
up to 26 months
Secondary outcome [5] 0 0
Time to CV mortality
Timepoint [5] 0 0
up to 26 months

Eligibility
Key inclusion criteria
1. Of full age of consent (according to local legislation, at least = 18 years) at screening.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
4. Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
5. High risk of HF, defined as EITHER

1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.

OR
2. Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
6. In addition at least one of the following risk factors:

* Age > 65 years,
* Newly developed LVEF < 35%,
* Prior MI (before index MI) documented in medical records,
* Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
* Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
* Type 2 diabetes mellitus (prior or new diagnosis),
* N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
* Uric acid >7.5 mg/dL (>446 µmol/L), measured at any time during hospitalisation,
* Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation),
* Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
* 3-vessel coronary artery disease at time of index MI,
* Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of chronic Heart Failure (HF) prior to index MI.
2. Systolic blood pressure < 90 mmHg at randomisation.
3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
4. Coronary Artery Bypass Grafting planned at time of randomisation.
5. Current diagnosis of Takotsubo cardiomyopathy.
6. Any current severe (stenotic or regurgitant) valvular heart disease.
7. eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
8. Type I diabetes mellitus. Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/11/2023
Sample size
Target
Accrual to date
Final
6522
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
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South Western Sydney Local Health District - Liverpool
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Royal North Shore Hospital - St Leonards
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Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
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Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
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4032 - Chermside
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4029 - Herston
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4215 - Southport
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
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Country [202] 0 0
Netherlands
State/province [202] 0 0
Capelle Aan Den Ijssel
Country [203] 0 0
Netherlands
State/province [203] 0 0
Eindhoven
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State/province [204] 0 0
Enschede
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State/province [205] 0 0
Goes
Country [206] 0 0
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State/province [206] 0 0
Groningen
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State/province [207] 0 0
Haarlem
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Heerlen
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Hertogenbosch
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Hilversum
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Hoorn
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Leiden
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Tiel
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Tilburg
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Zwolle
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State/province [217] 0 0
Belchatow
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Poland
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Bialystok
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Poland
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Bielsko-Biala
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Poland
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Chorzow
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Gdynia
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Sztum
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Pitesti
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Sibiu
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Russian Federation
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Russian Federation
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Tyumen
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Serbia
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Nis
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Serbia
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Serbia
State/province [271] 0 0
Subotica
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Serbia
State/province [272] 0 0
Uzice
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Serbia
State/province [273] 0 0
Zajecar
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Serbia
State/province [274] 0 0
Zrenjanin
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Spain
State/province [275] 0 0
Badalona
Country [276] 0 0
Spain
State/province [276] 0 0
Barcelona
Country [277] 0 0
Spain
State/province [277] 0 0
Madrid
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Spain
State/province [278] 0 0
Tarragona
Country [279] 0 0
Spain
State/province [279] 0 0
Vigo
Country [280] 0 0
Ukraine
State/province [280] 0 0
Cherkasy
Country [281] 0 0
Ukraine
State/province [281] 0 0
Dnepropetrovsk
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Ukraine
State/province [282] 0 0
Ivano-Frankivsk
Country [283] 0 0
Ukraine
State/province [283] 0 0
Kharkiv
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Ukraine
State/province [284] 0 0
Khmelnytskyi
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Ukraine
State/province [285] 0 0
Kiev
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Ukraine
State/province [286] 0 0
Lutsk
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Ukraine
State/province [287] 0 0
Lviv
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Ukraine
State/province [288] 0 0
Odesa
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Ukraine
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Ternopil
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Ukraine
State/province [290] 0 0
Uzhgorod
Country [291] 0 0
Ukraine
State/province [291] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04509674