NCT05050500

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Diabete Type 2
• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg/Tab	patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months
DRUG	control group	patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months.

Timeline

• Start date: 2023-05-08
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-09-20
• Last updated: 2026-01-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study