Study identifier:D169DC00001
ClinicalTrials.gov identifier:NCT04564742
EudraCT identifier:2020-000664-31
CTIS identifier:N/A
A Registry-based, Randomised, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on Cardiometabolic Outcomes in Patients without Diabetes with Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure
Acute Myocardial Infarction
Phase 3
No
Dapagliflozin, Placebo
All
4017
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
Uppsala Clinical Research Center
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.
Location
Location
Sheffield, United Kingdom, S5 7AU
Location
Blackpool, United Kingdom, FY3 8NR
Location
Leicester, United Kingdom, LE3 9QP
Location
Bradford, United Kingdom, BD9 6RJ
Location
Hull, United Kingdom, HU16 5JQ
Location
Newcastle upon Tyne, United Kingdom, NE7 7DN
Location
Headington, United Kingdom, OX3 9DU
Location
Wolverhampton, United Kingdom, WV10 0QP
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo | Drug: Dapagliflozin Dapagliflozin 10 mg tablets given once daily, per oral use Other Name: Forxiga TM Other Name: Farxiga TM |
Placebo Comparator: Placebo Placebo matching dapagliflozin | Drug: Placebo Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use |
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