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

Who is this study for? Patients with Myocardial Infarction, Diabetes Type 2
What treatments are being studied? Dapagliflozin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Mengmei Li
RECRUITING
Qingdao
Contact Information
Primary
Mengmei Li, MD
sjogen@163.com
0086053284961672
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 300
Treatments
Experimental: Intervention Group
Dapagliflozin 10 mg every 24 hours for 6 months
Placebo_comparator: Control Group
1 placebo tablet every 24 hours for 6 months
Sponsors
Leads: Qingdao Central Hospital

This content was sourced from clinicaltrials.gov