Acute Myocardial Infarction (AMI)Phase 4DAPOPTOSIS-MINCT06615674
Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients With Acute Myocardial Infarction
A Phase 4 study testing Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia in people with Acute Myocardial Infarction (AMI) and STEMI - ST Elevation Myocardial Infarction (MI), run by Yoga Yudhistira at 1 site in Indonesia.
Trial summary
The currently known Sodium-Glucose Transporter 2 (SGLT-2) inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects, including improvements in endothelial dysfunction, inhibition of platelet activation, reduction in autophagy processes… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
- What is being tested?
- Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Sep 2024to 7 Dec 2024
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Acute Myocardial Infarction (STEMI or NSTEMI) according to the Fourth Universal Definition of Myocardial Infarction from the European Society of Cardiology, American College of Cardiology, American Heart Association, and World Heart Federation.
- Aged 18-75 years
- Willing to participate in the study and sign informed consent.
Who cannot join
- Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hr) \<24 hours before randomization
- Patients with ketoacidosis (arterial pH \<7.30, serum bicarbonate \<18 mEq/l, positive ketonuria)
- Patients with impaired renal function with an estimated glomerular filtration rate (eGFR) \<20 ml/min or requiring dialysis
- Patients with a history of chronic heart failure before the onset of Acute Myocardial Infarction
- Patients scheduled for coronary artery bypass surgery
- Patients with type 1 diabetes mellitus
Show all 11Show fewer
- Patients with severe valvular disease
- Patients with sepsis
- Patients with symptomatic acute urinary tract infection
- Pregnant patients
- Patients with severe aortic stenosis or LVOT obstruction
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126
Surakarta, Central of Java, 57126
About this study
Official title: The Effect of Dapagliflozin on the Apoptosis Levels of Patients With Acute Myocardial Infarction - DAPOPTOSIS-MI (a Randomized Controlled Trial)
The currently known Sodium-Glucose Transporter 2 (SGLT-2) inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects, including improvements in endothelial dysfunction, inhibition of platelet activation, reduction in autophagy processes, oxidative stress, and inflammation, as well as inhibition of the Na+/H+ exchanger pathway, which potentially reduces cell damage and death resulting from ischemia and reperfusion processes. Research on the benefits of SGLT-2 inhibitors in pre-clinical studies with myocardial infarction has shown a significant reduction in myocardial apoptosis, indicated by reduced levels of caspase-3 and the apoptosis index. Additionally, there was an increase in ketone bodies and myocardial ATP, reduced levels of inflammatory cytokines, free radicals, and infarct area, as well as improvements in left ventricular ejection fraction. However, large-scale studies in humans have thus far been limited to investigating the effects of SGLT-2 inhibitors on mortality, rehospitalization rates due to heart failure, cardiometabolic factors, and improvements in remodeling parameters in myocardial infarction patients, with the use of empagliflozin or dapagliflozin. Based on literature reviews, there have been no studies to date that directly demonstrate the effects of dapagliflozin on apoptosis (caspase-3 levels) in myocardial infarction patients.
Read the detailed description
The study is a randomized controlled trial, single-center study in Acute Myocardial Infarction (AMI) patients held in Moewardi General Hospital, Central Java, Indonesia. The investigator divided 40 patients with AMI into two groups, the first is the Dapagliflozin group, which will get 10mg of Dapagliflozin once a day every morning and the second group will have a placebo once a day every morning also for 14 days. Each patient will be checked for Caspase-3 level from blood serum as primary outcome and Global Work (GW) echocardiographic parameters such as GWI, GCW, GWW, and GWE as secondary outcome at admission and 14 days after intervention. The study was approved by the hospital ethics committee. The clinical parameters above will then be analyzed. To determine the mean difference between unpaired groups (treatment and control), an independent T-test is used if the distribution is normal (if not, the Mann-Whitney test is used). Normality testing is performed using the Shapiro-Wilk test, considering the sample size is less than 50.
- Conditions
- Acute Myocardial Infarction (AMI), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
- Being tested
- Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
- Keywords
- AMI, STEMI, NSTEMI, Dapagliflozin, Apoptosis, Caspase-3, Myocardial Work
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, IndonesiaDrug
The first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | The intervention group will have dapagliflozin 10mg once a day every morning besides standard treatment of Acute Coronary Syndrome for 14 days before further evaluation Receives: Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia |
| Control | Experimental | The first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days. Receives: Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biomolecular Parameters
Change in Caspase-3 (ng/L) level in blood serum patients
Measured: 14 days
Secondary outcomes (1)
Change in Echocardiographic Parameters
Change in Global Work Index (GWI) (mmHg%), Global Constructive Work (GCW) (mmHg%), Global Wasted Work (GWW) (mmHg%), Global Work Efficiency (GWE) (%) parameter from patients
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start21 Sep 2024
- Primary completion30 Nov 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial and Double Blind (Researcher \&amp;amp;amp;amp;amp;amp;amp; Patients)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yoga Yudhistira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yoga Yudhistira, Universitas Sebelas Maret
- Investigators
- Yoga Yudhistira MD, Principal investigator, Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126Ahmad Yasa MD, Study director, Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615674
- Sponsor's protocol ID
- S5121020014865
- Acronym
- DAPOPTOSIS-MI
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was conducted as part of the final project for the cardiovascular residency program, there was no sponsorship during this study therefore the IPD cannot be shared
Publications
James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.
PubMed 38320489Hernandez AF, Udell JA, Jones WS, Anker SD, Petrie MC, Harrington J, Mattheus M, Seide S, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, A Figtree G, Ge J, G Goodman S, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Butler J. Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial. Circulation. 2024 May 21;149(21):1627-1638. doi: 10.1161/CIRCULATIONAHA.124.069217. Epub 2024 Apr 6.
PubMed 38581389Tanajak P, Sa-Nguanmoo P, Sivasinprasasn S, Thummasorn S, Siri-Angkul N, Chattipakorn SC, Chattipakorn N. Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. J Endocrinol. 2018 Feb;236(2):69-84. doi: 10.1530/JOE-17-0457. Epub 2017 Nov 15.
PubMed 29142025Jin W, Wang L, Zhu T, Ma Y, Yu C, Zhang F. Usefulness of echocardiographic myocardial work in evaluating the microvascular perfusion in STEMI patients after revascularization. BMC Cardiovasc Disord. 2022 May 13;22(1):218. doi: 10.1186/s12872-022-02648-z.
PubMed 35562649Chen S, Coronel R, Hollmann MW, Weber NC, Zuurbier CJ. Direct cardiac effects of SGLT2 inhibitors. Cardiovasc Diabetol. 2022 Mar 18;21(1):45. doi: 10.1186/s12933-022-01480-1.
PubMed 35303888McIlwain DR, Berger T, Mak TW. Caspase functions in cell death and disease. Cold Spring Harb Perspect Biol. 2015 Apr 1;7(4):a026716. doi: 10.1101/cshperspect.a026716. No abstract available.
PubMed 25833847Teringova E, Tousek P. Apoptosis in ischemic heart disease. J Transl Med. 2017 May 1;15(1):87. doi: 10.1186/s12967-017-1191-y.
PubMed 28460644
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dapagliflozin on the Apoptosis Levels of Patients With Acute Myocardial Infarction - DAPOPTOSIS-MI (a Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06615674
- Acronym / sponsor ID
- DAPOPTOSIS-MI / S5121020014865
- Conditions
- Acute Myocardial Infarction (AMI), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
- Keywords
- AMI, STEMI, NSTEMI, Dapagliflozin, Apoptosis, Caspase-3, Myocardial Work
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yoga YudhistiraUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 26 Sep 2024 (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.
The currently known Sodium-Glucose Transporter 2 (SGLT-2) inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects, including improvements in endothelial dysfunction, inhibition of platelet activation, reduction in autophagy processes, oxidative stress, and inflammation, as well as inhibition of the Na+/H+ exchanger pathway, which potentially reduces cell damage and death resulting from ischemia and reperfusion processes. Research on the benefits of SGLT-2 inhibitors in pre-clinical studies with myocardial infarction has shown a significant reduction in myocardial apoptosis, indicated by reduced levels of caspase-3 and the apoptosis index. Additionally, there was an increase in ketone bodies and myocardial ATP, reduced levels of inflammatory cytokines, free radicals, and infarct area, as well as improvements in left ventricular ejection fraction. However, large-scale studies in humans have thus far been limited to investigating the effects of SGLT-2 inhibitors on mortality, rehospitalization rates due to heart failure, cardiometabolic factors, and improvements in remodeling parameters in myocardial infarction patients, with the use of empagliflozin or dapagliflozin. Based on literature reviews, there have been no studies to date that directly demonstrate the effects of dapagliflozin on apoptosis (caspase-3 levels) in myocardial infarction patients.
Detailed description
The study is a randomized controlled trial, single-center study in Acute Myocardial Infarction (AMI) patients held in Moewardi General Hospital, Central Java, Indonesia. The investigator divided 40 patients with AMI into two groups, the first is the Dapagliflozin group, which will get 10mg of Dapagliflozin once a day every morning and the second group will have a placebo once a day every morning also for 14 days. Each patient will be checked for Caspase-3 level from blood serum as primary outcome and Global Work (GW) echocardiographic parameters such as GWI, GCW, GWW, and GWE as secondary outcome at admission and 14 days after intervention. The study was approved by the hospital ethics committee. The clinical parameters above will then be analyzed. To determine the mean difference between unpaired groups (treatment and control), an independent T-test is used if the distribution is normal (if not, the Mann-Whitney test is used). Normality testing is performed using the Shapiro-Wilk test, considering the sample size is less than 50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial and Double Blind (Researcher \&amp;amp;amp;amp;amp;amp;amp; Patients)
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, IndonesiaThe intervention group will have dapagliflozin 10mg once a day every morning besides standard treatment of Acute Coronary Syndrome for 14 days before further evaluation |
| Control | Experimental | Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, IndonesiaThe first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Acute Myocardial Infarction (STEMI or NSTEMI) according to the Fourth Universal Definition of Myocardial Infarction from the European Society of Cardiology, American College of Cardiology, American Heart Association, and World Heart Federation.
- Aged 18-75 years
- Willing to participate in the study and sign informed consent.
Key exclusion criteria (11 listed)
- Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hr) \<24 hours before randomization
- Patients with ketoacidosis (arterial pH \<7.30, serum bicarbonate \<18 mEq/l, positive ketonuria)
- Patients with impaired renal function with an estimated glomerular filtration rate (eGFR) \<20 ml/min or requiring dialysis
- Patients with a history of chronic heart failure before the onset of Acute Myocardial Infarction
- Patients scheduled for coronary artery bypass surgery
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 |
|---|---|---|
| Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, IndonesiaThe first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days. | Drug | Control, Dapagliflozin |
Primary outcome
Change in Biomolecular Parameters
Time frame: 14 days
Change in Caspase-3 (ng/L) level in blood serum patients
1 secondary outcome
Change in Echocardiographic Parameters
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 38320489James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.
- Background: PubMed 38581389Hernandez AF, Udell JA, Jones WS, Anker SD, Petrie MC, Harrington J, Mattheus M, Seide S, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, A Figtree G, Ge J, G Goodman S, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Butler J. Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial. Circulation. 2024 May 21;149(21):1627-1638. doi: 10.1161/CIRCULATIONAHA.124.069217. Epub 2024 Apr 6.
- Background: PubMed 29142025Tanajak P, Sa-Nguanmoo P, Sivasinprasasn S, Thummasorn S, Siri-Angkul N, Chattipakorn SC, Chattipakorn N. Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. J Endocrinol. 2018 Feb;236(2):69-84. doi: 10.1530/JOE-17-0457. Epub 2017 Nov 15.
- Background: PubMed 35562649Jin W, Wang L, Zhu T, Ma Y, Yu C, Zhang F. Usefulness of echocardiographic myocardial work in evaluating the microvascular perfusion in STEMI patients after revascularization. BMC Cardiovasc Disord. 2022 May 13;22(1):218. doi: 10.1186/s12872-022-02648-z.
- Background: PubMed 35303888Chen S, Coronel R, Hollmann MW, Weber NC, Zuurbier CJ. Direct cardiac effects of SGLT2 inhibitors. Cardiovasc Diabetol. 2022 Mar 18;21(1):45. doi: 10.1186/s12933-022-01480-1.
- Background: PubMed 25833847McIlwain DR, Berger T, Mak TW. Caspase functions in cell death and disease. Cold Spring Harb Perspect Biol. 2015 Apr 1;7(4):a026716. doi: 10.1101/cshperspect.a026716. No abstract available.
- Background: PubMed 28460644Teringova E, Tousek P. Apoptosis in ischemic heart disease. J Transl Med. 2017 May 1;15(1):87. doi: 10.1186/s12967-017-1191-y.
- Individual participant dataSharing planned: No. This study was conducted as part of the final project for the cardiovascular residency program, there was no sponsorship during this study therefore the IPD cannot be shared
Related trials for Acute Myocardial Infarction (AMI)
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Yoga Yudhistira MD principal investigator
Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126
Ahmad Yasa MD study director
Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia in people with Acute Myocardial Infarction (AMI) and STEMI - ST Elevation Myocardial Infarction (MI), run by Yoga Yudhistira at 1 site in Indonesia.
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 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Biomolecular Parameters (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615674, which also lists 7 linked publications.
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 27 Feb 2025.