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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03591991
Other study ID # 2018-04
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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