Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI

Reperfusion Injury, Myocardial Clinical Trial

Official title:

Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03591991
• Other study ID #: 2018-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: July 2018
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single-center, prospective controlled trial addressing effectiveness of empagliflozin on cardiac-renal injury in patients with STEMI. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Investigators, participants, and other study personnel were blinded to the assigned treatment for the duration of the study. The primary objective of this study is to investigate the effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance (CMR) methods at 3 months. Key secondary endpoint: incidence of CIAKI within 48h after PCI. Inclusion Criteria:Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between Ocotor 2018 and January 2019. STEMI was defined as typical chest pain lasting >30 minutes within the previous 12 hours, a clear ST-segment elevation of >0.1 mV in two or more contiguous electrocardiographic leads, and elevated blood levels of troponin T.Exclusion Criteria:Cardiogenic shock ,Hypoglycaemia ,Diabetic ketoacidosis,Genital and urinary infections,History of myocardial infarction,Stent thrombosis,Previous coronary artery bypass surgery,Type 1 Diabetes,Severe hepatic insufficiency,Advanced cancer patients,eGFR<30 ml/min.

All patients were informed of the potential risks (genital mycotic infections, urinary tract infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit written informed consent before being included in the study. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Patients in the empagliflozin group were treated with empagliflozin whereas patients in the control group were given placebo. The treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin or placebo administered in the ambulance. After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: September 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018.

Exclusion Criteria:

• Cardiogenic shock

• Hypoglycaemia

• Diabetic ketoacidosis

• Genital and urinary infections

• History of myocardial infarction

• Stent thrombosis

• Previous coronary artery bypass surgery

• Type 1 Diabetes

• Severe hepatic insufficiency

• Advanced cancer patients

• eGFR<30 ml/min

Related Conditions & MeSH terms

• Myocardial Reperfusion Injury
• Reperfusion Injury
• Reperfusion Injury, Myocardial
• ST Elevation Myocardial Infarction
• Wounds and Injuries

Intervention

Drug:
• Empagliflozin
After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin . After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.

Other:
• placebo
After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg placebo . After admission, patients were treated with 10 mg placebo once daily for 3 mouths.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	final infarct size	the final infarct size measured by Cardiac magnetic resonance	3 months after PCI
Secondary	contrast induced acute kidney injury (CIAKI)	incidence of CIAKI within 48 hours after PCI	within 48 hours after PCI