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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Dapagliflozin for Congestive Heart Failure (DAPA-MI Trial)

Phase 3
Waitlist Available
Led By Stefan James
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Congestive Heart Failure
  • Heart Failure
  • Heart Attack

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

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: DapagliflozinExperimental Treatment1 Intervention
Patients will be randomized 1:1 to either dapagliflozin or placebo
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching dapagliflozin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,105,088 Total Patients Enrolled
Uppsala UniversityOTHER
507 Previous Clinical Trials
3,163,798 Total Patients Enrolled
Stefan JamesPrincipal InvestigatorUppsala University
~831 spots leftby Nov 2025
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