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

NCT03591991 | Unknown

• 1 other identifier: 2018-04
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reperfusion Injury, Myocardial

Keywords

Empagliflozin; Percutaneous coronary intervention; Reperfusion Injury; Microvascular protection; CI-AKI; No-Reflow Phenomenon

Outcome Measures

Primary Outcomes (1)

• final infarct size

  the final infarct size measured by Cardiac magnetic resonance

  3 months after PCI

Secondary Outcomes (1)

• contrast induced acute kidney injury (CIAKI)

  within 48 hours after PCI

Study Arms (2)

treatment group

ACTIVE COMPARATOR

Patients will be randomized into two groups after enrolled. In Empagliflozin Group, 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. The procedure will double blind to patients and investigators.

Drug: Empagliflozin

Placebo group

PLACEBO COMPARATOR

Patients will be randomized into two groups after enrolled. In Placebo Group, 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. The procedure will double blind to patients and investigators.

Other: placebo

Interventions

Empagliflozin DRUG

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.

treatment group

placebo OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Reperfusion Injury; No-Reflow Phenomenon

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 19, 2018
• Study Start: October 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: September 1, 2019
• Last Updated: July 19, 2018

Record last verified: 2018-07