ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03591991
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dandan Li, Chinese PLA General Hospital

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.


Condition or disease Intervention/treatment Phase
Reperfusion Injury, Myocardial Drug: Empagliflozin Other: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: treatment group
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
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.

Placebo Comparator: Placebo group
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
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 Measures :
  1. final infarct size [ Time Frame: 3 months after PCI ]
    the final infarct size measured by Cardiac magnetic resonance


Secondary Outcome Measures :
  1. contrast induced acute kidney injury (CIAKI) [ Time Frame: within 48 hours after PCI ]
    incidence of CIAKI within 48 hours after PCI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Dandan Li, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03591991     History of Changes
Other Study ID Numbers: 2018-04
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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

Keywords provided by Dandan Li, Chinese PLA General Hospital:
Empagliflozin
Percutaneous coronary intervention
Reperfusion Injury
Microvascular protection
CI-AKI
No-Reflow Phenomenon

Additional relevant MeSH terms:
Empagliflozin
Wounds and Injuries
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiomyopathies
Hypoglycemic Agents
Physiological Effects of Drugs