Trial · NCT04564742

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

NCT04564742, Phase 3, Completed, AstraZeneca; results first posted 2025-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack. Trials, record NCT04564742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04564742

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
NCT number: NCT04564742
Status: Completed
Phases: Phase 3
Enrollment: 4,017 participants, actual
Lead sponsor: AstraZeneca
Conditions: Acute Myocardial Infarction, Heart Failure
Interventions: Dapagliflozin, Placebo
First posted: 2020-09-25
Last updated: 2025-03-07
Other registries' IDs: eudract:2020-000664-31
Results first posted: 2025-03-07

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	29 months	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	29 months	All participants are included in the analysis; Each row item displays the number of participants for the given event, and without preceding events defined in the hierarchical order.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Dapa 10 mg	The hierachical composite endpoint of all components	1990	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Placebo	The hierachical composite endpoint of all components	1970	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Dapa 10 mg	Death, adjudicated	41	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Placebo	Death, adjudicated	33	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Dapa 10 mg	Hospitalisation due to HF	32	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Placebo	Hospitalisation due to HF	41	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Dapa 10 mg	Non-fatal MI	29	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Placebo	Non-fatal MI	32	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Dapa 10 mg	AF/Flutter event	8	Participants
Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set)	Placebo	AF/Flutter event	15	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dapa 10 mg	2,019
Overall Study	STARTED	Placebo	1,998
Overall Study	COMPLETED	Dapa 10 mg	2,014
Overall Study	COMPLETED	Placebo	1,994
Overall Study	NOT COMPLETED	Dapa 10 mg	5
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events706

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Normocytic anaemia	Blood and lymphatic system disorders	Dapa 10 mg	1	2,019	1
serious	Normocytic anaemia	Blood and lymphatic system disorders	Placebo	0	1,998	0
serious	Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Dapa 10 mg	1	2,019	1
serious	Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Placebo	0	1,998	0
serious	Upper gastrointestinal perforation	Gastrointestinal disorders	Dapa 10 mg	0	2,019	0
serious	Upper gastrointestinal perforation	Gastrointestinal disorders	Placebo	1	1,998	1
serious	Adverse drug reaction	General disorders	Dapa 10 mg	1	2,019	1
serious	Adverse drug reaction	General disorders	Placebo	0	1,998	0
serious	Cardiac death	General disorders	Dapa 10 mg	1	2,019	1
serious	Cardiac death	General disorders	Placebo	0	1,998	0

1 to 10 of 706Source ClinicalTrials.gov

See all 706 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dapa 10 mg	41	2,019
Total, all-cause mortality	Placebo	33	1,998
Total, other adverse events	Dapa 10 mg	0	2,019
Total, other adverse events	Placebo	0	1,998
Total, serious adverse events	Dapa 10 mg	449	2,019
Total, serious adverse events	Placebo	404	1,998

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37648579	DERIVED	PubMed
38320489	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dapa 10 mg vs Placebo: deaths from any cause	Trial comparisons
Dapa 10 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04564742

GET https://conductscience.org/api/trials/v1/NCT04564742/events?page=2

API reference For AI assistants