Trials / Completed
CompletedNCT04564742
Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,017 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin | Dapagliflozin 10 mg tablets given once daily, per oral use |
| DRUG | Placebo | Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use |
Timeline
- Start date
- 2020-12-22
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
- First posted
- 2020-09-25
- Last updated
- 2025-03-07
- Results posted
- 2025-03-07
Locations
103 sites across 2 countries: Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04564742. Inclusion in this directory is not an endorsement.