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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050500
• Other study ID #: DAFLO-CH
• Secondary ID: DAFLO
• Status: Recruiting
• Phase: Phase 4
• Start date: May 8, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: May 2023
• Source: Qingdao Central Hospital
• Contact: Mengmei Li, MD
• Phone: 0086053284961672
• Email: sjogen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Dapagliflozin 10mg/Tab
patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months
• Placebo
patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.

Locations

Country	Name	City	State
China	Mengmei Li	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

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