Role of SGLT2I in Patients With Myocardial Infarction | NCT06245980

Studies
Role of SGLT2I in Patients With Myocardial Infarction

NCT06245980

Sponsor

Dongying Zhang

Status

Unknown status

Last Update Posted

Feb 8, 2024Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Myocardial Infarction
Diabetes Mellitus

Interventions

SGLT2 inhibitor

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Mar 31, 2024Estimated

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With SGLT2I			Drug: SGLT2 inhibitor
Without SGLT2i

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGLT2 inhibitor	Drug	According to whether SGLT2i was used	With SGLT2I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	cardiovascular death and heart failure and myocardial infarction	24months
Heart failure readmission	Heart failure readmission	24months

Secondary Outcomes

Measure	Description	Time Frame
Recurrent myocardial infarction	Recurrent myocardial infarction	24months
cardiovascular death	cardiovascular death	24months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myocardial infarction patients
Type 2 diabetics.

Exclusion Criteria:

Patients undergoing coronary artery bypass grafting (CABG).
Severe valvular heart disease.
Contraindications of secondary medical preventive therapy for myocardial infarction, such as β-blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin-converting enzyme inhibitors (ARBs), antiplatelets, and statins.
Previously used SGLT2i.
Severe hepatic and renal insufficiency.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Acute myocardial infarction patients with diabetes mellitus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xuesong wen	Contact	+8618702384027		1979272415@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400016	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40402390	Derived	Luo S, Liu H, Li Z, Zhou Y, He S, Zhang D, Qin S, Wen X. Effects of SGLT2 Inhibitor in Patients with Diabetes with Newly Diagnosed Acute Myocardial Infarction: A Multicenter Prospective Cohort Study. Cardiovasc Drugs Ther. 2026 Apr;40(2):543-554. doi: 10.1007/s10557-025-07716-y. Epub 2025 May 22.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents