AzTrials
AzTrials

Acute Coronary SyndromesPhase 4SAPT-ACSNCT07684742

Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome

A Phase 4 study testing Early P2Y12 Inhibitor Monotherapy and Standard Dual Antiplatelet Therapy in people with Acute Coronary Syndromes and STEMI, run by Gyeongsang National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, open-label, multicenter, randomized, phase IV clinical trial designed to evaluate the safety and efficacy of early aspirin discontinuation followed by potent P2Y12 inhibitor monotherapy after intravascular ultrasound (IVUS)-guided drug-eluting stent implantation in patients with acute coronary… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Acute Coronary Syndromes, STEMI, NSTEMI
What is being tested?
Early P2Y12 Inhibitor Monotherapy and Standard Dual Antiplatelet Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,200 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2026to 31 Jan 2033
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >=19 years
  • Diagnosis of acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)
  • Successful IVUS-guided PCI (with DES for culprit and DES or DCB for non-culprit lesions) achieving complete revascularization and meeting the mandatory procedural criteria
  • Randomization within 96 hours after PCI
  • Written informed consent

Who cannot join

  • Planned staged PCI or CABG
  • Mandatory procedural criteria not met (e.g., final TIMI flow <3, significant dissection, thrombus, or malapposition requiring correction)
  • In-stent restenosis lesion
  • Need for oral anticoagulation
  • Major bleeding within 30 days
  • History of hemorrhagic stroke or ischemic stroke within 6 months
Show all 11Show fewer
  • Platelet count <100,000/mm3 at screening
  • Contraindication to aspirin, ticagrelor, or prasugrel
  • Life expectancy <1 year
  • Current or potential pregnancy
  • Investigator deems participation inappropriate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin-Sin Koh, MD, PhD contact

+82-55-750-8467

kjs0175@gmail.com

South Korea1 site, 1 recruiting

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727

    Jin-Sin Koh, MD, PhD, +82-55-750-8467, kjs0175@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Early Single Antiplatelet Therapy With a Potent P2Y12 Inhibitor After Intravascular Ultrasound-Guided PCI in Patients With Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial

This is a prospective, open-label, multicenter, randomized, phase IV clinical trial designed to evaluate the safety and efficacy of early aspirin discontinuation followed by potent P2Y12 inhibitor monotherapy after intravascular ultrasound (IVUS)-guided drug-eluting stent implantation in patients with acute coronary syndrome. A total of 2,200 patients who achieve complete revascularization after IVUS-guided percutaneous coronary intervention (PCI) and meet the predefined successful IVUS-guided PCI criteria will be randomized in a 1:1 ratio to either the early single antiplatelet therapy group (Early SAPT: ticagrelor or prasugrel monotherapy) or the standard dual antiplatelet therapy group (Standard DAPT: aspirin plus ticagrelor or prasugrel). Randomization will be performed within 96 hours after completion of PCI, and clinical follow-up will be conducted at 1 month, 3 months, 6 months, and 12 months after randomization. The primary endpoints are major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction, ischemia-driven target vessel revascularization, and definite or probable stent thrombosis occurring up to 12 months after randomization, and clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding occurring up to 12 months after randomization. This study aims to determine whether early P2Y12 inhibitor monotherapy is non-inferior to standard dual antiplatelet therapy (DAPT) for ischemic events and is superior in reducing clinically relevant bleeding.

Read the detailed description

The study population will consist of patients diagnosed with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI) (using a drug-eluting stent (DES) for the culprit lesion, and a DES or drug-coated balloon (DCB) for non-culprit lesions), achieve complete revascularization (CR) of all clinically significant coronary lesions under intravascular ultrasound (IVUS) guidance, and meet the imaging criteria predefined in this study.Patients who meet all inclusion criteria and none of the exclusion criteria will be randomized within 96 hours after completion of PCI for CR, provided that no additional revascularization procedure is considered necessary. Before randomization, appropriate antiplatelet therapy including aspirin and a P2Y12 inhibitor may be administered according to the standard practice of each participating center. If staged PCI is planned, study enrollment and randomization will be allowed only after completion of all planned procedures. After the operator confirms successful procedural completeness based on final angiographic and IVUS images, eligible participants will be randomized in an open-label manner in a 1:1 ratio. After randomization, the treatment strategy will be as follows. In the early single antiplatelet therapy (Early SAPT) group, aspirin will be discontinued immediately after randomization once CR has been confirmed, and potent P2Y12 inhibitor monotherapy will be administered as prasugrel 10 mg once daily or ticagrelor 90 mg twice daily. In the standard dual antiplatelet therapy (Standard DAPT) group, aspirin 100 mg once daily will be administered in combination with prasugrel 10 mg once daily or ticagrelor 90 mg twice daily. All patients will continue standard cardiovascular preventive therapy, including high-intensity statin therapy, beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), or angiotensin receptor blockers (ARBs), as appropriate. A proton pump inhibitor (PPI) may be used at the discretion of the treating physician in patients at risk of gastrointestinal bleeding. All randomized study participants will undergo clinical follow-up at 1 month, 3 months, 6 months, and 12 months after randomization.

Being tested
Early P2Y12 Inhibitor Monotherapy, Standard Dual Antiplatelet Therapy
Keywords
Intravascular Ultrasound, Percutaneous Coronary Intervention, Drug-Eluting Stent, Single Antiplatelet Therapy, Dual Antiplatelet Therapy
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early P2Y12 Inhibitor MonotherapyDrug

    Participants randomized within 96 hours after successful IVUS-guided PCI will discontinue aspirin immediately after randomization and receive potent P2Y12 inhibitor monotherapy with ticagrelor 90 mg twice daily or prasugrel 10 mg once daily. However, in patients aged ≥75 years, weighing <60 kg, or considered at high bleeding risk, a reduced dose of ticagrelor (60 mg twice daily) or prasugrel (5 mg once daily) may be administered at the operator's discretion.

  • Standard Dual Antiplatelet TherapyDrug

    Participants randomized within 96 hours after successful IVUS-guided PCI will receive aspirin 100 mg once daily plus a potent P2Y12 inhibitor, consisting of ticagrelor 90 mg twice daily or prasugrel 10 mg once daily, for 12 months. However, in patients aged ≥75 years, weighing <60 kg, or considered at high bleeding risk, a reduced dose of ticagrelor (60 mg twice daily) or prasugrel (5 mg once daily) may be administered at the operator's discretion.

Study groups in NCT07684742
Study groupRoleWhat they receive
Early Single Antiplatelet Therapy GroupExperimentalPatients with acute coronary syndrome who undergo successful IVUS-guided PCI with complete revascularization will be randomized within 96 hours after PCI. After randomization, aspirin will be discontinued immediately, and patients will receive potent P2Y12 inhibitor monotherapy with either prasugrel or ticagrelor.
Receives: Drug: Early P2Y12 Inhibitor Monotherapy
Standard Dual Antiplatelet Therapy GroupActive comparatorPatients with acute coronary syndrome who undergo successful IVUS-guided PCI with complete revascularization will receive standard dual antiplatelet therapy consisting of aspirin plus a potent P2Y12 inhibitor for 12 months.
Receives: Drug: Standard Dual Antiplatelet Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiovascular Events

    Major adverse cardiovascular events are defined as a composite of all-cause death, myocardial infarction, stroke, and urgent target vessel revascularization occurring up to 12 months after randomization.

    Measured: Up to 12 months after randomization

  2. Clinically Relevant Bleeding

    Clinically relevant bleeding is defined as the incidence of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events occurring up to 12 months after randomization.

    Measured: Up to 12 months after randomization

Secondary outcomes (11)

  1. Incidence of Major and Minor Bleeding According to TIMI Criteria

    TIMI bleeding definitions:

    • Major: Any intracranial bleeding (excluding microhemorrhages 10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of 5 g/dL, Fatal bleeding (bleeding that directly results in death within 7 d)
    • Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to 5 g/dL, requiring medical attention, any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above, requiring intervention (medical practitioner-guided medical or surgical treatment to stop or treat bleeding, including, temporarily or permanently discontinuing or changing the dose of a medication or study drug), leading to or prolonging hospitalization, prompting evaluation (leading to an unscheduled visit to a healthcare professional and diagnostic testing, either laboratory or imaging).

    Measured: Up to 12 months after randomization

  2. Incidence of Major and Minor Bleeding According to ISTH Criteria

    • Major:
    1. Fatal bleeding and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or
    3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
    • Minor:

    All non-major bleeds will be considered minor bleeds. Minor bleeds will be further divided into those that are clinically relevant and those that are not.

    Measured: Up to 12 months after randomization

  3. Incidence of All-Cause Death

    All-cause mortality was used rather than cardiac mortality to eliminate the need for possibly difficult adjudication of causes of death, especially given the relatively low mortality expected.

    In addition, the cause of death will be adjudicated as being due to cardiovascular causes, non-cardiovascular causes, or undetermined causes.

    • Cardiovascular death includes sudden cardiac death, death due to acute MI, heart failure or cardiogenic shock, stroke, other cardiovascular causes, or bleeding
    • Non-cardiovascular death is defined as any death with known cause not of cardiac or vascular causes
    • Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a noncardiovascular cause. For this trial all deaths of undetermined cause will be included in the cardiovascular category

    Measured: Up to 12 months after randomization

  4. Incidence of Myocardial Infarction

    The definition of MI is based on the SCAI definition of clinically relevant MI. MI is defined as an abnormal cardiac biomarker level above the institutional upper limit of normal (either cardiac troponin or CK-MB), and either at least 1 of the following: a) Symptoms of myocardial ischemia, b) New or presumed new significant ST-segment-T wave (ST-T) changes or new LBBB on the ECG, c) Development of pathological Q waves on the ECG, d) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, e) Identification of an intracoronary thrombus by angiography or autopsy.

    Measured: Up to 12 months after randomization

  5. Incidence of Ischemia-Driven Target Vessel Revascularization

    A coronary revascularization procedure may be either a CABG or a PCI.

    • Target Vessel: The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion including upstream and downstream branches and the target lesion itself All revascularization events will be adjudicated as either ischemia-driven or non-ischemia-driven. Revascularization will be considered ischemia-driven if the diameter stenosis of the revascularized coronary segment is ≥50% by QCA and any of the following criteria for ischemia are met: a) History of angina pectoris, presumably related to the target vessel, b) Objective signs of ischemia at rest (electrocardiographic changes) or during exercise test (or equivalent), presumably related to the target vessel c) Abnormal results of any invasive functional diagnostic test (e.g., CFR or FFR).

    Measured: Up to 12 months after randomization

  6. Incidence of Definite or Probable Stent Thrombosis

    • Definite stent thrombosis: defined as occurring when clinical presentation is consistent with acute coronary syndrome and angiography or autopsy examination confirm stent occlusion or thrombus.
    • Probable stent thrombosis: defined as death occurring within 30 days that cannot be attributed to another cause or when myocardial infarction occurs at any time point and is attributable to the target vessel in the absence of angiography confirming another culprit lesion.
    • Possible stent thrombosis: defined as occurring when the patient dies after >30 days and death is not explained by another cause.

    Measured: Up to 12 months after randomization

  7. Incidence of Net Adverse Clinical Events

    Net adverse clinical events are defined as a composite of major adverse cardiovascular events and clinically relevant bleeding. Major adverse cardiovascular events include all-cause death, myocardial infarction, stroke, and urgent target vessel revascularization. Clinically relevant bleeding is defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.

    Measured: Up to 12 months after randomization

  8. All-Cause Rehospitalization Rate

    All-cause rehospitalization is defined as any hospital admission occurring after randomization, regardless of cause. Rehospitalization events will be collected during follow-up and classified according to the reason for admission, including cardiovascular, bleeding-related, and non-cardiovascular causes.

    Measured: Up to 12 months after randomization

  9. Medication Adherence

    Medication adherence is defined as adherence to the assigned antiplatelet treatment strategy during follow-up. At each follow-up visit, antiplatelet therapy status, discontinuation, switching, interruption, and compliance with aspirin, ticagrelor, or prasugrel will be assessed.

    Measured: Up to 12 months after randomization

  10. Survival Rate at 12 Months

    Survival rate at 12 months is defined as the proportion of randomized participants who are alive at 12 months after randomization. Vital status will be assessed at follow-up, and deaths will be adjudicated according to cause when available.

    Measured: At 12 months after randomization

  11. Stroke

    Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, lasting ≥24 hours or confirmed by neuroimaging. Strokes will be classified as ischemic, hemorrhagic, or undetermined.

    Measured: Up to 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completion1 Jul 2031 (estimated)
  4. Study completion31 Jan 2033 (estimated)

Resources

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
Open-label, multicenter, randomized, parallel-group trial comparing early potent P2Y12 inhibitor monotherapy versus standard dual antiplatelet therapy after successful IVUS-guided PCI in patients with acute coronary syndrome.
Masking
None (open label)
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684742
Sponsor's protocol ID
SAPT-ACS
Acronym
SAPT-ACS
Status last verified
Nov 2026
First submitted
29 Jun 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the data contain potentially sensitive clinical information and data sharing is subject to institutional review board approval and data-use agreements.

Publications

  • Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

    PubMed 39210710

  • Guimaraes PO, Franken M, Tavares CAM, Antunes MO, Silveira FS, Andrade PB, Bergo RR, Joaquim RM, Tinoco de Paula JE, Nascimento BR, Pitta FG, Arruda JA, Serpa RG, Ohe LN, Mangione FM, Furtado RHM, Ferreira E, Sampaio FBA, T do Nascimento C, Genelhu LOO, Bezerra CG, Sarmento-Leite R, Maia LN, Oliveira FRA, Wainstein MV, Dall'Orto FTC, Monfardini F, Assis SRL, Nicolau JC, Sposito AC, Lopes RD, Onuma Y, Valgimigli M, Angiolillo DJ, Serruys PWJC, Berwanger O, Bacal F, Lemos PA; NEO-MINDSET Trial Investigators. Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes. N Engl J Med. 2025 Nov 27;393(21):2095-2106. doi: 10.1056/NEJMoa2507980. Epub 2025 Aug 31.

    PubMed 40888723

  • Lee SY, Jeong YH, Yun KH, Cho JY, Gorog DA, Angiolillo DJ, Kim JW, Jang Y. P2Y12 Inhibitor Monotherapy Combined With Colchicine Following PCI in ACS Patients: The MACT Pilot Study. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1845-1855. doi: 10.1016/j.jcin.2023.05.035.

    PubMed 37587591

  • Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

    PubMed 34449185

  • Mehran R, Baber U, Sharma SK, Cohen DJ, Angiolillo DJ, Briguori C, Cha JY, Collier T, Dangas G, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.

    PubMed 31556978

  • Kim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.

    PubMed 32543684

  • Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.

    PubMed 30166073

  • Hahn JY, Song YB, Oh JH, Chun WJ, Park YH, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437. doi: 10.1001/jama.2019.8146.

    PubMed 31237645

  • Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.

    PubMed 31237644

  • Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.

    PubMed 27026020

  • Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.

    PubMed 32860058

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Early P2Y12 Inhibitor Monotherapy and Standard Dual Antiplatelet Therapy in people with Acute Coronary Syndromes and STEMI, run by Gyeongsang National University Hospital at 1 site in South Korea.

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 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin-Sin Koh, MD, PhD (+82-55-750-8467, kjs0175@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (time frame: Up to 12 months after randomization). The study lists 2 primary outcomes in all. 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 NCT07684742, which also lists 11 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 5 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in