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

NCT05050500 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: DAFLO-CHDAFLO
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

myocardial infarction; dapagliflozin; MACE events

Outcome Measures

Primary Outcomes (4)

• MACE events

  To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.

  12 months

• Post-infarction angina

  Evaluate the post-infarction angina occurence in both groups

  12 months

• The rate of heart failure occurrence

  Assess the rate of new-onset heart failure during the study follow-up.

  12 months

• IL-6

  Serum IL-6 level

  baseline, 1 month, 3 month, 6 month, 12 month

Secondary Outcomes (2)

• IL-1β

  baseline, 1 month, 3 month, 6 month, 12 month

• hs-CRP

  baseline, 1 month, 3 month, 6 month, 12 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

Dapagliflozin 10 mg every 24 hours for 12 months

Drug: Dapagliflozin 10mg/Tab

Control Group

OTHER

AMI standard therapy for 12 months

Drug: control group

Interventions

control group DRUG

patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months.

Control Group

Dapagliflozin 10mg/Tab DRUG

patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months

Also known as: Dapagliflozin Group

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with Type 1 Diabetes Mellitus.
• Patients with renal dysfunction. (GFR\<90mmol/L).
• Patients who have recently undergone immunosuppressive therapy.
• Patients with a history of recurrent urinary tract infections.
• Patients who are known to be allergic to SGLT-2 inhibitors.
• Patients who are hemodynamically unstable.
• Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
• 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.
• Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Mengmei Li

Qingdao, Shandong, 266042, China

Location

MeSH Terms

Conditions

Myocardial Infarction; Diabetes Mellitus, Type 2; Glucose Intolerance

Interventions

dapagliflozin; Control Groups

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Weisheng Liu, MD

  Qingdao Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: May 8, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)