Clinical trial NCT03591991: Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI
Official title: Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reperfusion Injury, Myocardial
Keywords: Empagliflozin
Percutaneous coronary intervention
Reperfusion Injury
Microvascular protection
CI-AKI
No-Reflow Phenomenon
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: final infarct size
timeFrame: 3 months after PCI
Secondary outcomes:
measure: contrast induced acute kidney injury (CIAKI)
timeFrame: within 48 hours after PCI
Other outcomes:
Locations:
Study officials:
References: