Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome (SAPT-ACS)

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 1,900 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unstable Angina; STEMI; Acute Coronary Syndromes; NSTEMI
• Intervention / Treatment: Drug: Early P2Y12 Inhibitor Monotherapy; Drug: Standard Dual Antiplatelet Therapy

Detailed Description

The study population will consist of patients diagnosed with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI), 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.

• Study Type: Interventional
• Enrollment (Estimated): 1900
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin-Sin Koh, MD, PhD; Phone Number: +82-55-750-8467; Email: kjs0175@gmail.com

Study Locations

• South Korea
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • GyeongSang National University Hospital
      • Contact: Jin-Sin Koh, MD, PhD; Phone Number: +82-55-750-8467; Email: kjs0175@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age >=18 years
2. Diagnosis of acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)
3. Successful IVUS-guided PCI with drug-eluting stent implantation
4. Randomization within 96 hours after PCI
5. Written informed consent

Exclusion Criteria:

1. Planned staged PCI or CABG
2. PCI failure, including no-reflow, major dissection, or thrombosis
3. Need for oral anticoagulation
4. Major bleeding within 30 days
5. History of hemorrhagic stroke or ischemic stroke within 6 months
6. Platelet count <100,000/mm3 or WBC count <3,000/mm3
7. Contraindication to aspirin, ticagrelor, or prasugrel
8. Life expectancy <1 year
9. Current or potential pregnancy
10. Investigator deems participation inappropriate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Single Antiplatelet Therapy Group; Patients 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.	Drug: Early P2Y12 Inhibitor Monotherapy; 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.
Active Comparator: Standard Dual Antiplatelet Therapy Group; Patients 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.	Drug: Standard Dual Antiplatelet Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	Major adverse cardiovascular events are 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.	Up to 12 months after randomization
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.	Up to 12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 months after randomization
Incidence of Major and Minor Bleeding According to ISTH Criteria	Major:Fatal bleeding and/orSymptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome.and/orBleeding 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.	Up to 12 months after randomization
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	Up to 12 months after randomization
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.	Up to 12 months after randomization
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).	Up to 12 months after randomization
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.	Up to 12 months after randomization
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, ischemia-driven target vessel revascularization, and definite or probable stent thrombosis. Clinically relevant bleeding is defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.	Up to 12 months after randomization
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.	Up to 12 months after randomization
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.	Up to 12 months after randomization
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.	At 12 months after randomization

Collaborators and Investigators

• Sponsor: Gyeongsang National University Hospital
• Collaborators: Biotronik SE & Co. KG; Genoss Co., Ltd.; CGBio Inc.; Dio Medical
• Investigators: Principal Investigator: Jin-Sin Koh, MD, PhD, GyeongSang National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; Drug-Eluting Stent; Intravascular Ultrasound; Single Antiplatelet Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
• Other Study ID Numbers: SAPT-ACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No