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Myocardial InfarctionPhase 4NCT05050500

Effects of Dapagliflozin on Inflammatory Factorslevel and Prognosis in Type 2 Diabetes With Acute Myocardial Infarction

A Phase 4 study testing Dapagliflozin 10mg/Tab in people with Myocardial Infarction and Diabete Type 2, run by Qingdao Central Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Dapagliflozin 10mg/Tab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteChina
Study dates
8 May 2023to 30 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
  • Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Who cannot join

  • Patients diagnosed with Type 1 Diabetes Mellitus.
  • Patients with renal dysfunction. (GFR<90mmol/L).
  • Patients who have recently undergone immunosuppressive therapy.
  • Patients with a history of recurrent urinary tract infections.
  • Patients who are known to be allergic to SGLT-2 inhibitors.
  • Patients who are hemodynamically unstable.
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  • Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
  • Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
  • Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
  • Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Mengmei Li

    Qingdao, Shandong, 266042

Other trials in China

About this study

Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.

  1. Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829.
  2. Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.
Being tested
Dapagliflozin 10mg/Tab, control group
Keywords
myocardial infarction, dapagliflozin, MACE events
Medical subject headings
Myocardial Infarction, Diabetes Mellitus, Type 2, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 10mg/TabDrug

    Also called Dapagliflozin Group

    patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months

  • control groupDrug

    patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months.

Study groups in NCT05050500
Study groupRoleWhat they receive
Intervention GroupExperimentalDapagliflozin 10 mg every 24 hours for 12 months
Receives: Drug: Dapagliflozin 10mg/Tab
Control GroupOtherAMI standard therapy for 12 months
Receives: Drug: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE events

    To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.

    Measured: 12 months

  2. Post-infarction angina

    Evaluate the post-infarction angina occurence in both groups

    Measured: 12 months

  3. The rate of heart failure occurrence

    Assess the rate of new-onset heart failure during the study follow-up.

    Measured: 12 months

  4. IL-6

    Serum IL-6 level

    Measured: baseline, 1 month, 3 month, 6 month, 12 month

Secondary outcomes (2)

  1. IL-1β

    Serum IL-1β

    Measured: baseline, 1 month, 3 month, 6 month, 12 month

  2. hs-CRP

    hs-CRP

    Measured: baseline, 1 month, 3 month, 6 month, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start8 May 2023
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05050500
Sponsor's protocol ID
DAFLO-CH
Other IDs
DAFLO
Status last verified
Dec 2025
First submitted
9 Sep 2021
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin 10mg/Tab in people with Myocardial Infarction and Diabete Type 2, run by Qingdao Central Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE events (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05050500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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