Reperfusion Injury, MyocardialNCT03591991
Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI
A study testing Empagliflozin in people with Reperfusion Injury, Myocardial, run by Chinese PLA General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reperfusion Injury, Myocardial
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018.
Who cannot join
- Cardiogenic shock
- Hypoglycaemia
- Diabetic ketoacidosis
- Genital and urinary infections
- History of myocardial infarction
- Stent thrombosis
Show all 11Show fewer
- Previous coronary artery bypass surgery
- Type 1 Diabetes
- Severe hepatic insufficiency
- Advanced cancer patients
- eGFR<30 ml/min
About this study
Official title: Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.
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
- Being tested
- Empagliflozin, placebo
- Keywords
- Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon
- Medical subject headings
- Myocardial Reperfusion Injury, Reperfusion Injury, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
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.
placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
final infarct size
the final infarct size measured by Cardiac magnetic resonance
Measured: 3 months after PCI
Secondary outcomes (1)
contrast induced acute kidney injury (CIAKI)
incidence of CIAKI within 48 hours after PCI
Measured: within 48 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reperfusion Injury, MyocardialStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dandan Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591991
- Sponsor's protocol ID
- 2018-04
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT03591991
- Acronym / sponsor ID
- 2018-04
- Conditions
- Reperfusion Injury, Myocardial
- Keywords
- Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: EmpagliflozinPatients 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. |
| Placebo group | Placebo comparator | Other: placeboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018.
Key exclusion criteria (11 listed)
- Cardiogenic shock
- Hypoglycaemia
- Diabetic ketoacidosis
- Genital and urinary infections
- History of myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAfter 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. | Drug | treatment group |
| placeboAfter 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. | Other | Placebo group |
Primary outcome
final infarct size
Time frame: 3 months after PCI
the final infarct size measured by Cardiac magnetic resonance
1 secondary outcome
contrast induced acute kidney injury (CIAKI)
Time frame: within 48 hours after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin in people with Reperfusion Injury, Myocardial, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
final infarct size (time frame: 3 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.