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

Sponsor
AstraZeneca
Study ID
NCT04564742
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg tablets given once daily, per oral use
  • Placebo — DRUG
    Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use

Study Details

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.

Key Dates

Start date
Dec 22, 2020
Status verified
Feb 2025
Primary completion
Jul 5, 2023
Completion
Jul 5, 2023

Study Design

Enrollment
4,017 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Patients will be randomized 1:1 to either dapagliflozin or placebo
  • Placebo Comparator: Placebo
    Placebo matching dapagliflozin

Primary Outcome Measure

Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set) [ Time Frame: 29 months ]

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