STEMI - ST Elevation Myocardial InfarctionNCT05045274
The Effect of Early Administration of Dapagliflozin in STEMI Patients With LV Systolic Dysfunction
A study testing Dapagliflozin 10Mg Tab in people with STEMI - ST Elevation Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Assiut University.
Trial summary
300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Left Ventricular Systolic Dysfunction
- What is being tested?
- Dapagliflozin 10Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st time STEMI within 24 hours undergoing PPCI. (Chest pain > 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI. (published at ESC Clinical Practice Guidelines 2012).
- LVEF less than 50%.
- eGFR ≥20 mL/min/1.73 m2.
Who cannot join
- Patients less than 18 years old.
- T1D (Type I diabetes mellitus).
- Hemodynamically unstable.
- Cardiogenic shock (clinical syndrome of tissue hypoperfusion resulting from cardiac dysfunction).
- History of chronic symptomatic HF with a prior hHF within last year
- Patients on dialysis.
Show all 9Show fewer
- Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema).
- Pregnant or lactating women.
- Sever hepatic impairment.
About this study
Official title: The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction
300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5
Read the detailed description
300 STIMI patients with LV systolic dysfunction will be randomly divided into two equal groups (Group I (Study arm, n=150); will receive
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
- Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI.
Group (II) Control arm (n=150); will receive
- Reperfusion therapy: as in study arm
- Anti-ischemic treatment: as in study arm.
- Anti-failure treatment: as in study arm. LV echocardiographic analysis for both groups at baseline and 3 month follow up by 2D Echocardiography to assess: LVEF by simpson method Diastolic function LV diameter and volume. LA volume index. LV mass index. Severity of MR.
Laboratory investigation substudy analysis:
50 patients from either group will undergo NT-proBNP at baseline and after 3 month follow up.
Clinical outcomes:
Patients will be followed up in a deducted outpatient clinic for assessment of clinical outcomes either by phone cell or clinic visits at 3 month.
Patients will be assessed for the following clinical parameters:
- Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
Research outcome measures:
- Primary (main):
- The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography.
- Secondary (subsidiary):
- Echocardiographic parameters at 3 month follow up.
- Changes in LV remodeling.
- Changes in diastolic function
- Changes in LA volume index.
- Changes in LV mass index.
- Laboratory investigations. Changes of the NT-proBNP from baseline to 3 month follow up
- Clinical outcomes at 3month. I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Also called aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
- Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI.
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
PlaceboDrug
Also called aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin | Active comparator | (a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month Receives: Drug: Dapagliflozin 10Mg Tab |
| conventional therapy | Placebo comparator | 1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic parameter
The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography
Measured: 3 month follow up
Secondary outcomes (8)
Changes in LV remodeling
using echocardiography
Measured: 3 month follow up
Changes in diastolic function
using mitral Inflow Patterns electrocardiography
Measured: 3 month follow up
Changes in LA volume index
using by the biplane area-length method from apical 4- and 2-chamber views electrocardiography
Measured: 3 month follow up
Changes in LV mass index.
using by linear method electrocardiography
Measured: 3 month follow up
Laboratory investigations.
Changes of the NT-proBNP from baseline to 3 month follow up
Measured: 3 month follow up
CV death and rehospitalization of HF
Composite of CV death and rehospitalization of HF
Measured: 3 month follow up
Individual component at composite end points.
Composite of CV death or rehospitalization of HF
Measured: 3 month follow up
ACS
Reinfarction or readmission for ACS and target lesion revascularization.
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George William Agban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045274
- Sponsor's protocol ID
- GAgban
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT05045274
- Acronym / sponsor ID
- GAgban
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Sep 2021 (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.
300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5
Detailed description
300 STIMI patients with LV systolic dysfunction will be randomly divided into two equal groups (Group I (Study arm, n=150); will receive
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
- Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI.
Group (II) Control arm (n=150); will receive
- Reperfusion therapy: as in study arm
- Anti-ischemic treatment: as in study arm.
- Anti-failure treatment: as in study arm. LV echocardiographic analysis for both groups at baseline and 3 month follow up by 2D Echocardiography to assess: LVEF by simpson method Diastolic function LV diameter and volume. LA volume index. LV mass index. Severity of MR.
Laboratory investigation substudy analysis:
50 patients from either group will undergo NT-proBNP at baseline and after 3 month follow up.
Clinical outcomes:
Patients will be followed up in a deducted outpatient clinic for assessment of clinical outcomes either by phone cell or clinic visits at 3 month.
Patients will be assessed for the following clinical parameters:
- Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
Research outcome measures:
- Primary (main):
- The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography.
- Secondary (subsidiary):
- Echocardiographic parameters at 3 month follow up.
- Changes in LV remodeling.
- Changes in diastolic function
- Changes in LA volume index.
- Changes in LV mass index.
- Laboratory investigations. Changes of the NT-proBNP from baseline to 3 month follow up
- Clinical outcomes at 3month. I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dapagliflozin | Active comparator | Drug: Dapagliflozin 10Mg Tab(a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month |
| conventional therapy | Placebo comparator | Drug: Placebo1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1st time STEMI within 24 hours undergoing PPCI. (Chest pain > 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI. (published at ESC Clinical Practice Guidelines 2012).
- LVEF less than 50%.
- eGFR ≥20 mL/min/1.73 m2.
Key exclusion criteria (9 listed)
- Patients less than 18 years old.
- T1D (Type I diabetes mellitus).
- Hemodynamically unstable.
- Cardiogenic shock (clinical syndrome of tissue hypoperfusion resulting from cardiac dysfunction).
- History of chronic symptomatic HF with a prior hHF within last year
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 |
|---|---|---|
| Dapagliflozin 10Mg TabAlso: aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.1. Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI. 2. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 3. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 4. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload. | Drug | dapagliflozin |
| PlaceboAlso: aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload. | Drug | conventional therapy |
Primary outcome
Echocardiographic parameter
Time frame: 3 month follow up
The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography
8 secondary outcomes
Changes in LV remodeling
Time frame: 3 month follow up
Changes in diastolic function
Time frame: 3 month follow up
Changes in LA volume index
Time frame: 3 month follow up
Changes in LV mass index.
Time frame: 3 month follow up
Laboratory investigations.
Time frame: 3 month follow up
CV death and rehospitalization of HF
Time frame: 3 month follow up
Individual component at composite end points.
Time frame: 3 month follow up
ACS
Time frame: 3 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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 Dapagliflozin 10Mg Tab in people with STEMI - ST Elevation Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Assiut University.
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 3 inclusion and 9 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 16 Sep 2021. 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?
Echocardiographic parameter (time frame: 3 month follow up). 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 16 Sep 2021.