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DAPA-PROTECTOR: Dapagliflozin for Cardiac Remodeling After Acute Myocardial Infarction
NCT05764057Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2023
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- dapagliflozin
- Conditions
- acute myocardial infarction (AMI)left ventricular dysfunction
01
Overview
Phase 3, randomised, double-blind trial in acute myocardial infarction (AMI) and left ventricular dysfunction comparing Dapagliflozin 10mg daily + standard of care with Placebo + standard of care (2 arms). Primary endpoints: Change in left ventricular ejection fraction at 6 months and Change in left atrium volume at 6 months. Started Jun 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dapagliflozin 10mg daily + standard of care
Dapagliflozin 10mg per day administered orally for 6 months
Placebo + standard of care
Placebo administered orally for 6 months
03
Who it enrols
Adults with STEMI or very high-risk NSTEMI and LV dysfunction (LVEF <= 45%) after PCI, with adequate renal function and blood pressure, excluding those with cardiogenic shock, prior SGLT2 inhibitor use, or non-type 2 diabetes.
04
Endpoints
Primary
Change in left ventricular ejection fraction
Change in left atrium volume
Secondary
Change in left ventricular end-systolic volume
Change in left ventricular end-diastolic volume
Change in LV global longitudinal strain
Change in left atrial strain
Duration of hospital stay
All-cause mortality
Cardiovascular death or worsening HF
Number of re-admission due to HF
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