The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

September 15, 2023 updated by: Qingdao Central Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mengmei Li, MD
  • Phone Number: 0086053284961672
  • Email: sjogen@163.com

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Mengmei Li
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
  3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Exclusion Criteria:

  1. Patients diagnosed with Type 1 Diabetes Mellitus.
  2. Patients with renal dysfunction. (GFR<90mmol/L).
  3. Patients who have recently undergone immunosuppressive therapy.
  4. Patients with a history of recurrent urinary tract infections.
  5. Patients who are known to be allergic to SGLT-2 inhibitors.
  6. Patients who are hemodynamically unstable.
  7. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
  8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
  9. 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.
  10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Dapagliflozin 10 mg every 24 hours for 6 months
Drug: Dapagliflozin 10mg/Tab
patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months
Other Names:
  • Dapagliflozin Group
Placebo Comparator: Control Group
1 placebo tablet every 24 hours for 6 months
Drug: Placebo
patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.
Other Names:
  • Placebo Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE events
Time Frame: 6 months
To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.
6 months
Left ventricular ejection fraction,left ventricle end-systolic volume (LVESV), and left ventricular end-diastolic volume
Time Frame: 6 months
Evaluate baseline left ventricular ejection fraction (LVEF) and left ventricular end- diastolic volume(LVEDV) in post-MI patients and 6 months of treatment.
6 months
Post-infarction angina
Time Frame: 6 months
Evaluate the post-infarction angina occurence in both groups
6 months
The rate of heart failure occurrence
Time Frame: 6 months
Assess the rate of new-onset heart failure during the study follow-up.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Investigators

  • Study Director: Weisheng Liu, MD, Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAFLO-CH
  • DAFLO (Registry Identifier: DAFLO-CH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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