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SGLT2 Inhibitor

Dapagliflozin for Heart Attack (DAPA STEMI Trial)

Phase 3
Waitlist Available
Led By Michel LeMay, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ischemic chest discomfort of ≥30 minutes duration
Anterior STEMI with ST-segment elevation ≥2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6)
Must not have
Age < 18 years
Any contraindication to undergo CMR imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, and 6 months
Awards & highlights
Pivotal Trial

Summary

This trial will test if SGLT2i can help reduce infarct size in patients having a heart attack & referred for PPCI. Cardiac MRI will measure the effect.

Who is the study for?
This trial is for patients who have had a severe type of heart attack known as STEMI and are going to undergo primary percutaneous coronary intervention (PPCI). The specific details about who can join or must avoid the trial aren't provided here.
What is being tested?
The study is testing if a diabetes medication called Dapagliflozin can reduce the damage to the heart muscle in patients with STEMI. Participants will be randomly assigned to receive either Dapagliflozin or a placebo, alongside their standard treatment.
What are the potential side effects?
While not specified here, common side effects of Dapagliflozin may include yeast infections, urinary tract infections, increased urination, and potential risk of dehydration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chest pain lasting 30 minutes or more.
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I had a severe heart attack with specific EKG changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I cannot have CMR imaging due to health reasons.
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I have Type 1 diabetes.
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My doctor expects me to live more than a year despite my non-heart related condition.
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I have been diagnosed with severe heart valve disease.
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I have heart failure and was hospitalized for it in the last year.
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I have had a heart attack before.
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I have severe liver problems.
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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Infarct Size
Secondary study objectives
Acute Kidney Injury
Cardiogenic Shock
Multiple Cardiac Adverse Events (MACE)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment2 Interventions
Dapagliflozin 10mg daily X 7 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo daily X 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10mg Tab
2022
Completed Phase 4
~1070
CMR
2014
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
93,244 Total Patients Enrolled
6 Trials studying Myocardial Infarction
3,595 Patients Enrolled for Myocardial Infarction
Michel LeMay, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
~43 spots leftby Feb 2025
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