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

Primary Purpose

Reperfusion Injury, Myocardial

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Empagliflozin
placebo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reperfusion Injury, Myocardial focused on measuring Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    treatment group

    Placebo group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    final infarct size
    the final infarct size measured by Cardiac magnetic resonance

    Secondary Outcome Measures

    contrast induced acute kidney injury (CIAKI)
    incidence of CIAKI within 48 hours after PCI

    Full Information

    First Posted
    July 8, 2018
    Last Updated
    July 17, 2018
    Sponsor
    Chinese PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03591991
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    January 31, 2019 (Anticipated)
    Study Completion Date
    September 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese PLA General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reperfusion Injury, Myocardial
    Keywords
    Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Empagliflozin
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    final infarct size
    Description
    the final infarct size measured by Cardiac magnetic resonance
    Time Frame
    3 months after PCI
    Secondary Outcome Measure Information:
    Title
    contrast induced acute kidney injury (CIAKI)
    Description
    incidence of CIAKI within 48 hours after PCI
    Time Frame
    within 48 hours after PCI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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