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

Sponsor
Qingdao Central Hospital
Study ID
NCT05050500
Phase
PHASE4
Status
Completed

Conditions

  • Diabete Type 2
  • Glucose Intolerance
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
Dec 2025
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
143 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Dapagliflozin 10 mg every 24 hours for 12 months
  • Other: Control Group
    AMI standard therapy for 12 months

Primary Outcome Measure

MACE events [ Time Frame: 12 months ]

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