Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack. (DAPA-MI Trial)
Palo Alto (17 mi)Overseen byStefan James
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapagliflozinExperimental Treatment1 Intervention
Patients will be randomized 1:1 to either dapagliflozin or placebo
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching dapagliflozin
Dapagliflozin is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Forxiga for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
🇺🇸 Approved in United States as Farxiga for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
🇨🇦 Approved in Canada as Farxiga for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
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Who is running the clinical trial?
AstraZenecaLead Sponsor
Uppsala UniversityCollaborator