STEMI - ST Elevation Myocardial Infarction (MI)Phase 2NCT06850831
Early Intracoronary N-Acetylcysteine During Primary PCI in STEMI: A Pilot Randomized Trial of Reperfusion Injury Biomarkers and Functional Recovery
A Phase 2 study testing Antipac in people with STEMI - ST Elevation Myocardial Infarction (MI) and Primary PCI - STEMI, run by dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA at 1 site in Indonesia.
Trial summary
Myocardial ischemia-reperfusion injury still poses a major therapeutic challenge in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction (MI), Primary PCI - STEMI
- What is being tested?
- Antipac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patients 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 Treated by Primary PCI.
- Aged 18-65 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/hour) <24 hours before randomization
- Patients with a history of myocardial infarction
- Patients with a history of chronic heart failure before the onset of AMI
- Patients scheduled for coronary artery bypass surgery
- Patients with chronic renal failure or requiring dialysis
- Patients with chronic inflammation
Show all 16Show fewer
- Patients with malignancy
- Patients with a history of hyper/hypothyroidism
- Patients with acute infection
- Patients with sepsis
- Patients with acute stroke
- Patients with pulmonary fibrosis
- Patients with a history of autoimmune disease
- Patients with a history of anti-inflammatory / antioxidant supplementation
- Patients with allergy to N-acetylcysteine
- Pregnant and lactating patients
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi General Hospital
Surakarta, Central of Java, 57126
About this study
Myocardial ischemia-reperfusion injury still poses a major therapeutic challenge in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). N-acetylcysteine (NAC) is a thiol-containing antioxidant and precursor to glutathione, and may attenuate oxidative stress, inflammatory activation, apoptosis-related signaling and myocardial damage during early reperfusion. However, evidence from clinical trials exploring early intracoronary NAC delivery during PPCI is still limited.
We performed a pilot randomised, double-blind, placebo-controlled trial to determine whether early intracoronary N-acetylcysteine (NAC) administration during primary percutaneous coronary intervention (PPCI) reduces biomarker responses to reperfusion injury and is associated with functional recovery in patients with ST elevation myocardial infarction (STEMI). Participants will be randomized to intracoronary NAC or intracoronary placebo in addition to standard PPCI and guideline based STEMI therapy. The main outcome is the change in malondialdehyde (MDA) from baseline to 24 hours after PPCI. Secondary outcomes include changes in high-sensitivity troponin I, interleukin-6 and caspase-3 and global longitudinal strain and metabolic equivalents derived from the six-minute walk test during follow-up.
Read the detailed description
The standard reperfusion strategy for patients with ST-segment elevation myocardial infarction is primary percutaneous coronary intervention. While PPCI restores epicardial coronary blood flow and limits ischemic myocardial injury, the process of reperfusion itself may contribute to additional myocardial damage through myocardial ischemia-reperfusion injury. It is mediated through several interacting mechanisms including generation of reactive oxygen species, lipid peroxidation, inflammatory activation, endothelial dysfunction, mitochondrial injury, calcium overload, and programmed cell death.
N-acetylcysteine is an antioxidant with a thiol group and a glutathione precursor which may have cardioprotective effects in ischemia-reperfusion. NAC may reduce oxidative stress by donating thiols, by repleting intracellular glutathione, and by modulating reactive oxygen species . It may also modulate pathways involved in inflammation and apoptosis that are activated during early myocardial reperfusion. Prior studies in the clinical setting of NAC in acute myocardial infarction have largely been administered orally or intravenously. Evidence is limited for direct intracoronary delivery of NAC during PPCI.
This is a pilot, randomized, double-blind, placebo-controlled trial of early intracoronary NAC administration in STEMI patients undergoing PPCI. Eligible patients are adults undergoing PPCI for STEMI who give written informed consent. Participants will be randomized 1:1 to intracoronary NAC or intracoronary placebo in addition to standard PPCI and guideline-directed medical therapy.
In the intervention arm intracoronary NAC is given at a dose of 480 mg diluted in 10 mL normal saline. NAC is administered as early as possible during reperfusion after guidewire crossing when any antegrade coronary flow has been established. If crossing the guidewire alone does not restore flow, NAC is given after initial balloon dilatation when minimal flow is obtained. Solution is delivered through a microcatheter positioned proximal to the culprit lesion over 10 minutes. In the control arm, participants receive an intracoronary placebo of 10 mL normal saline by the same method and duration. The placebo solution appears and has the same volume as the NAC solution to maintain the blinding.
The primary end point was change in serum malondialdehyde from baseline to 24 h after PPCI. Circulating marker of oxidative stress and lipid peroxidation in early reperfusion. MDA . Secondary mechanistic end points are change from baseline to 24 hours after PPCI in high-sensitivity troponin I, interleukin-6, and caspase-3. High-sensitivity troponin I is used as a marker for release of the biomarker of myocardial injury, interleukin-6 as a marker for inflammatory response, and caspase-3 as a marker related to apoptosis.
Secondary functional end points are global longitudinal strain and metabolic equivalents from the six-minute walk test. Two-dimensional speckle-tracking echocardiography is used to measure global longitudinal strain at admission, discharge and 6 months after admission. Functional capacity was measured by the six-minute walk test at discharge and at 6 months, and the walking distance was expressed in metabolic equivalents.
This trial is intended to provide mechanistic and hypothesis-generating evidence regarding whether early intracoronary NAC during PPCI can attenuate reperfusion injury biomarker responses and support functional recovery signals in STEMI patients.
- Being tested
- Antipac
- Keywords
- STEMI, Primary PCI, Intracoronary NAC, Reperfusion Injury, Apoptosis, Necrosis, Oxidative Stress, Remodelling, Left ventricular dysfunction, Physical Recovery
- Medical subject headings
- ST Elevation Myocardial Infarction, Reperfusion Injury, Necrosis, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipacDrug
The first group is the NAC group, which will get intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI. And the second group will have placebo immediately after the lesion is opened during primary PCI.
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary NAC | Experimental | The intervention group will have intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI is performed besides standard treatment of STEMI before further evaluation. Receives: Drug: Antipac |
| Control | Placebo comparator | The intervention group will have intracoronary N-AC 480 mg immediately after the lesion is opened during primary PCI besides standard treatment of STEMI before further evaluation. Receives: Drug: Antipac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (ng/ml)
Improvements in Biomolecular Parameters (Oxidative Stress)
Measured: Baseline and 24 hours after intervention
Secondary outcomes (5)
hs-Troponin I (ng/L)
Myocardial necrosis parameter
Measured: Baseline and 24 hours after intervention
Caspase-3 (pg/dl)
Apoptosis parameter
Measured: Baseline and 24 hours after intervention
IL-6 (pg/dl)
Inflammation parameter
Measured: Baseline and 24 hours after intervention
Global Longitudinal Strain (%)
Improvements in Echocardiographic Parameters
Measured: Baseline, discharge at day-5, and 1 weeks after discharge
Improvements in Physical Parameters
6 Minutes Walking Test (METs)
Measured: Day-5 after intervention (at discharge) and 6-month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Apr 2025
- Primary completion30 Mar 2026
- Study completion30 Apr 2026
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 STEMI - ST Elevation Myocardial Infarction (MI)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized, double-blind, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA, Universitas Sebelas Maret
- Investigators
- Ahmad Yasa, MD, Principal investigator, Universitas Sebelas MaretTrisulo Wasyanto, Prof. DR.dr., Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850831
- Sponsor's protocol ID
- 374/II/HREC/2025
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2025
- Last updated
- 2 Oct 2026
- 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 doctoral program, there was no sponsorship during this study therefore the IPD cannot be shared
Publications
Liu HW, Han YL, Jin QM, Wang XZ, Ma YY, Wang G, Wang B, Xu K, Li Y, Chen SL. One-year Outcomes in Patients with ST-segment Elevation Myocardial Infarction Caused by Unprotected Left Main Coronary Artery Occlusion Treated by Primary Percutaneous Coronary Intervention. Chin Med J (Engl). 2018 Jun 20;131(12):1412-1419. doi: 10.4103/0366-6999.233948.
PubMed 29893357Yang C, Deng Z, Li J, Ren Z, Liu F. Meta-analysis of the relationship between interleukin-6 levels and the prognosis and severity of acute coronary syndrome. Clinics (Sao Paulo). 2021 Jul 5;76:e2690. doi: 10.6061/clinics/2021/e2690. eCollection 2021.
PubMed 34231707Aladag N, Asoglu R, Ozdemir M, Asoglu E, Derin AR, Demir C, Demir H. Oxidants and antioxidants in myocardial infarction (MI): Investigation of ischemia modified albumin, malondialdehyde, superoxide dismutase and catalase in individuals diagnosed with ST elevated myocardial infarction (STEMI) and non-STEMI (NSTEMI). J Med Biochem. 2021 Jun 5;40(3):286-294. doi: 10.5937/jomb0-28879.
PubMed 34177373Rathod KS, Hamshere S, Khambata RS, Andiapen M, Westwood M, Mathur A, Ahluwalia A, Jones DA. Combined analysis of the safety of intra-coronary drug delivery during primary percutaneous coronary intervention for acute myocardial infarction: A study of three clinical trials. JRSM Cardiovasc Dis. 2017 Aug 16;6:2048004017725988. doi: 10.1177/2048004017725988. eCollection 2017 Jan-Dec.
PubMed 29104752Pasupathy S, Tavella R, Grover S, Raman B, Procter NEK, Du YT, Mahadavan G, Stafford I, Heresztyn T, Holmes A, Zeitz C, Arstall M, Selvanayagam J, Horowitz JD, Beltrame JF. Early Use of N-acetylcysteine With Nitrate Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Reduces Myocardial Infarct Size (the NACIAM Trial [N-acetylcysteine in Acute Myocardial Infarction]). Circulation. 2017 Sep 5;136(10):894-903. doi: 10.1161/CIRCULATIONAHA.117.027575. Epub 2017 Jun 20.
PubMed 28634219Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
PubMed 23281415Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intracoronary N-Acetylcysteine During Primary PCI in STEMI: A Pilot Randomized Trial of Reperfusion Injury Biomarkers and Functional Recovery
- ClinicalTrials.gov ID
- NCT06850831
- Acronym / sponsor ID
- 374/II/HREC/2025
- Keywords
- STEMI, Primary PCI, Intracoronary NAC, Reperfusion Injury, Apoptosis, Necrosis, Oxidative Stress, Remodelling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FAUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Feb 2025 (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.
Myocardial ischemia-reperfusion injury still poses a major therapeutic challenge in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). N-acetylcysteine (NAC) is a thiol-containing antioxidant and precursor to glutathione, and may attenuate oxidative stress, inflammatory activation, apoptosis-related signaling and myocardial damage during early reperfusion. However, evidence from clinical trials exploring early intracoronary NAC delivery during PPCI is still limited.
We performed a pilot randomised, double-blind, placebo-controlled trial to determine whether early intracoronary N-acetylcysteine (NAC) administration during primary percutaneous coronary intervention (PPCI) reduces biomarker responses to reperfusion injury and is associated with functional recovery in patients with ST elevation myocardial infarction (STEMI). Participants will be randomized to intracoronary NAC or intracoronary placebo in addition to standard PPCI and guideline based STEMI therapy. The main outcome is the change in malondialdehyde (MDA) from baseline to 24 hours after PPCI. Secondary outcomes include changes in high-sensitivity troponin I, interleukin-6 and caspase-3 and global longitudinal strain and metabolic equivalents derived from the six-minute walk test during follow-up.
Detailed description
The standard reperfusion strategy for patients with ST-segment elevation myocardial infarction is primary percutaneous coronary intervention. While PPCI restores epicardial coronary blood flow and limits ischemic myocardial injury, the process of reperfusion itself may contribute to additional myocardial damage through myocardial ischemia-reperfusion injury. It is mediated through several interacting mechanisms including generation of reactive oxygen species, lipid peroxidation, inflammatory activation, endothelial dysfunction, mitochondrial injury, calcium overload, and programmed cell death.
N-acetylcysteine is an antioxidant with a thiol group and a glutathione precursor which may have cardioprotective effects in ischemia-reperfusion. NAC may reduce oxidative stress by donating thiols, by repleting intracellular glutathione, and by modulating reactive oxygen species . It may also modulate pathways involved in inflammation and apoptosis that are activated during early myocardial reperfusion. Prior studies in the clinical setting of NAC in acute myocardial infarction have largely been administered orally or intravenously. Evidence is limited for direct intracoronary delivery of NAC during PPCI.
This is a pilot, randomized, double-blind, placebo-controlled trial of early intracoronary NAC administration in STEMI patients undergoing PPCI. Eligible patients are adults undergoing PPCI for STEMI who give written informed consent. Participants will be randomized 1:1 to intracoronary NAC or intracoronary placebo in addition to standard PPCI and guideline-directed medical therapy.
In the intervention arm intracoronary NAC is given at a dose of 480 mg diluted in 10 mL normal saline. NAC is administered as early as possible during reperfusion after guidewire crossing when any antegrade coronary flow has been established. If crossing the guidewire alone does not restore flow, NAC is given after initial balloon dilatation when minimal flow is obtained. Solution is delivered through a microcatheter positioned proximal to the culprit lesion over 10 minutes. In the control arm, participants receive an intracoronary placebo of 10 mL normal saline by the same method and duration. The placebo solution appears and has the same volume as the NAC solution to maintain the blinding.
The primary end point was change in serum malondialdehyde from baseline to 24 h after PPCI. Circulating marker of oxidative stress and lipid peroxidation in early reperfusion. MDA . Secondary mechanistic end points are change from baseline to 24 hours after PPCI in high-sensitivity troponin I, interleukin-6, and caspase-3. High-sensitivity troponin I is used as a marker for release of the biomarker of myocardial injury, interleukin-6 as a marker for inflammatory response, and caspase-3 as a marker related to apoptosis.
Secondary functional end points are global longitudinal strain and metabolic equivalents from the six-minute walk test. Two-dimensional speckle-tracking echocardiography is used to measure global longitudinal strain at admission, discharge and 6 months after admission. Functional capacity was measured by the six-minute walk test at discharge and at 6 months, and the walking distance was expressed in metabolic equivalents.
This trial is intended to provide mechanistic and hypothesis-generating evidence regarding whether early intracoronary NAC during PPCI can attenuate reperfusion injury biomarker responses and support functional recovery signals in STEMI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Pilot randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intracoronary NAC | Experimental | Drug: AntipacThe intervention group will have intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI is performed besides standard treatment of STEMI before further evaluation. |
| Control | Placebo comparator | Drug: AntipacThe intervention group will have intracoronary N-AC 480 mg immediately after the lesion is opened during primary PCI besides standard treatment of STEMI before further evaluation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI patients 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 Treated by Primary PCI.
- Aged 18-65 years
- Willing to participate in the study and sign informed consent.
Key exclusion criteria (16 listed)
- Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output <0.5 ml/kg/hour) <24 hours before randomization
- Patients with a history of myocardial infarction
- Patients with a history of chronic heart failure before the onset of AMI
- Patients scheduled for coronary artery bypass surgery
- Patients with chronic renal failure or requiring dialysis
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 |
|---|---|---|
| AntipacThe first group is the NAC group, which will get intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI. And the second group will have placebo immediately after the lesion is opened during primary PCI. | Drug | Control, Intracoronary NAC |
Primary outcome
Malondialdehyde (ng/ml)
Time frame: Baseline and 24 hours after intervention
Improvements in Biomolecular Parameters (Oxidative Stress)
5 secondary outcomes
hs-Troponin I (ng/L)
Time frame: Baseline and 24 hours after intervention
Caspase-3 (pg/dl)
Time frame: Baseline and 24 hours after intervention
IL-6 (pg/dl)
Time frame: Baseline and 24 hours after intervention
Global Longitudinal Strain (%)
Time frame: Baseline, discharge at day-5, and 1 weeks after discharge
Improvements in Physical Parameters
Time frame: Day-5 after intervention (at discharge) and 6-month after discharge
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 2 Oct 2026.
- Background: PubMed 29893357Liu HW, Han YL, Jin QM, Wang XZ, Ma YY, Wang G, Wang B, Xu K, Li Y, Chen SL. One-year Outcomes in Patients with ST-segment Elevation Myocardial Infarction Caused by Unprotected Left Main Coronary Artery Occlusion Treated by Primary Percutaneous Coronary Intervention. Chin Med J (Engl). 2018 Jun 20;131(12):1412-1419. doi: 10.4103/0366-6999.233948.
- Background: PubMed 34231707Yang C, Deng Z, Li J, Ren Z, Liu F. Meta-analysis of the relationship between interleukin-6 levels and the prognosis and severity of acute coronary syndrome. Clinics (Sao Paulo). 2021 Jul 5;76:e2690. doi: 10.6061/clinics/2021/e2690. eCollection 2021.
- Background: PubMed 34177373Aladag N, Asoglu R, Ozdemir M, Asoglu E, Derin AR, Demir C, Demir H. Oxidants and antioxidants in myocardial infarction (MI): Investigation of ischemia modified albumin, malondialdehyde, superoxide dismutase and catalase in individuals diagnosed with ST elevated myocardial infarction (STEMI) and non-STEMI (NSTEMI). J Med Biochem. 2021 Jun 5;40(3):286-294. doi: 10.5937/jomb0-28879.
- Background: PubMed 29104752Rathod KS, Hamshere S, Khambata RS, Andiapen M, Westwood M, Mathur A, Ahluwalia A, Jones DA. Combined analysis of the safety of intra-coronary drug delivery during primary percutaneous coronary intervention for acute myocardial infarction: A study of three clinical trials. JRSM Cardiovasc Dis. 2017 Aug 16;6:2048004017725988. doi: 10.1177/2048004017725988. eCollection 2017 Jan-Dec.
- Background: PubMed 28634219Pasupathy S, Tavella R, Grover S, Raman B, Procter NEK, Du YT, Mahadavan G, Stafford I, Heresztyn T, Holmes A, Zeitz C, Arstall M, Selvanayagam J, Horowitz JD, Beltrame JF. Early Use of N-acetylcysteine With Nitrate Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Reduces Myocardial Infarct Size (the NACIAM Trial [N-acetylcysteine in Acute Myocardial Infarction]). Circulation. 2017 Sep 5;136(10):894-903. doi: 10.1161/CIRCULATIONAHA.117.027575. Epub 2017 Jun 20.
- Background: PubMed 23281415Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
- Background: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Individual participant dataSharing planned: No. This study was conducted as part of the final project for doctoral program, there was no sponsorship during this study therefore the IPD cannot be shared
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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.
Ahmad Yasa, MD principal investigator
Universitas Sebelas Maret
Trisulo Wasyanto, Prof. DR.dr. principal investigator
Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antipac in people with STEMI - ST Elevation Myocardial Infarction (MI) and Primary PCI - STEMI, run by dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA 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 16 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 2 Oct 2026. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Malondialdehyde (ng/ml) (time frame: Baseline and 24 hours after intervention). 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 NCT06850831, 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 2 Oct 2026.