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.
This is a multicentre, parallel group double-blind, placebo-controlled phase 3 registry-based randomised controlled trial (R-RCT) in patients without diabetes presenting with myocardial infarction (MI) (ST segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI)) and evidence of impaired regional or global LV systolic function or definite evidence of Q wave MI on ECG. In the study the effect of dapagliflozin versus placebo, given once daily in addition to SoC therapy will be evaluated for the hospitalisation for HF, CV death, and other cardiometabolic outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,017
Dapagliflozin 10 mg tablets given once daily, per oral use
Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)
Study participants received dapagliflozin 10 mg or matching placebo, given once daily in addition to SoC. Overall, the mean study duration was 12.0 months (time in study until last visit) with an accumulated 4023.9 participant-years. The maximum study duration for any participant was 29 months. "Number of Events" for NYHA corresponds to the number of participants with a non-missing value for NYHA functional class at the last visit, and that all participants with a non-missing value take part in the analysis comparing their NYHA class value with all other participants with a NYHA value, according to the win-ratio method.
Time frame: 29 months
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Research Site
Alingsås, Sweden
Research Site
Borås, Sweden
Research Site
Eskilstuna, Sweden
Research Site
Falun, Sweden
Research Site
Gävle, Sweden
Research Site
Gothenburg, Sweden
Research Site
Gothenburg, Sweden
Research Site
Halmstad, Sweden
Research Site
Hässleholm, Sweden
Research Site
Helsingborg, Sweden
...and 93 more locations