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

Primary Purpose

Myocardial Infarction, Diabete Type 2, Glucose Intolerance

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dapagliflozin 10mg/Tab

Placebo

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, dapagliflozin, MACE events

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
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).

Sites / Locations

Mengmei LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Dapagliflozin 10 mg every 24 hours for 6 months

1 placebo tablet every 24 hours for 6 months

Outcomes

Primary Outcome Measures

MACE events

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

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.

Post-infarction angina

Evaluate the post-infarction angina occurence in both groups

The rate of heart failure occurrence

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05050500

First Posted

September 9, 2021

Last Updated

September 15, 2023

Sponsor

Qingdao Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05050500

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 8, 2023 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qingdao Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Diabete Type 2, Glucose Intolerance

Keywords

myocardial infarction, dapagliflozin, MACE events

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Dapagliflozin 10 mg every 24 hours for 6 months

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

1 placebo tablet every 24 hours for 6 months

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin 10mg/Tab

Other Intervention Name(s)

Dapagliflozin Group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo Group

Intervention Description

patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.

Primary Outcome Measure Information:

Title

MACE events

Description

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

Time Frame

6 months

Title

Left ventricular ejection fraction,left ventricle end-systolic volume (LVESV), and left ventricular end-diastolic volume

Description

Evaluate baseline left ventricular ejection fraction (LVEF) and left ventricular end- diastolic volume(LVEDV) in post-MI patients and 6 months of treatment.

Time Frame

6 months

Title

Post-infarction angina

Description

Evaluate the post-infarction angina occurence in both groups

Time Frame

6 months

Title

The rate of heart failure occurrence

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mengmei Li, MD

Phone

0086053284961672

sjogen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weisheng Liu, MD

Organizational Affiliation

Qingdao Central Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Mengmei Li

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weisheng Liu, MD

Phone

0086053284961819

773524311@qq.com

First Name & Middle Initial & Last Name & Degree

Weisheng Liu

Phone

0086053284961819

773524311@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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