AzTrials
AzTrials

Chronic Coronary SyndromePIVOTNCT07577518

Comparison of the Incidence of Major Cardiovascular Events Between the Combination of Percutaneous Intervention and Optimal Drug Therapy and the Optimal Drug Therapy Alone in Patients With Chronic Coronary Syndrome

A study testing percutaneous coronary intervention, Guideline-directed Optimal Medical treatment and Carvedilol Sustained-Release (SR) (Nested RCT subset) in people with Chronic Coronary Syndrome, run by Seoul National University Hospital at 20 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Comparison of the incidence of major cardiovascular events between the combination of percutaneous intervention and optimal drug therapy and the optimal drug therapy alone in patients with chronic coronary syndrome. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Coronary Syndrome
What is being tested?
percutaneous coronary intervention, Guideline-directed Optimal Medical treatment and Carvedilol Sustained-Release (SR) (Nested RCT subset)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,301 participants
Where
20 sitesSouth Korea
Study dates
15 Jun 2026to 10 Mar 2034
Phase
Interventional
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 40 years or older
  • Patients suspected of having chronic coronary syndrome who have undergone coronary angiography and confirmed stenotic lesions
  • Patients with lesions suitable for stent insertion who have 50% or more visually estimated stenosis in major coronary arteries with a diameter of 2.5 mm or greater observed on coronary angiography, and who satisfy one or more of the following conditions:
  • Patients with stenosis of 70% or more confirmed via Quantitative coronary angiography (50% or more for the left main coronary artery)
  • Minimum lumen area (MLA) ≤ 4 mm² or plaque burden >70% on intravascular ultrasound (IVUS)
  • MLA <3.5 mm² or area stenosis (AS) >65% on Optical Coherence Tomography (OCT)
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  • The corresponding stenosis on localizing stress imaging using SPECT or PET When there is a significant focal ischemic deficit in the coronary artery region of the lesion and the total perfusion deficit (TPD) is ≥10%
  • Pressure wire-based fractional flow reserve (FFR) ≤0.80
  • Patients who can verbally confirm their understanding of invasive physiological or imaging evaluations and the benefits, harms, and alternative treatments of coronary angioplasty using drug-eluting stents, and for whom the patient or their legal representative can submit a written consent form.
  • Additional Criteria for nested RCT Studies
  • When heart rate control is deemed therapeutically important due to an accompanying increase in heart rate at rest or during symptomatic episodes.
  • When the use of beta-blockers is deemed clinically advantageous due to a history of myocardial infarction.
  • When beta-blockers can help control blood pressure and symptoms in cases of concomitant hypertension.
  • When there is a clinical situation requiring associated tachyarrhythmia or heart rate control.
  • When beta-blockers are deemed more appropriate due to a history of contraindications, intolerance, or side effects of calcium channel blockers.

Who cannot join

  • Patients with Left Ventricular Ejection Fraction (LVEF) less than 35%
  • Patients with cardiogenic shock
  • Patients with pulmonary edema or heart failure unresponsive to standard treatment
  • Patients with unstable angina whose symptoms persist despite maximal drug therapy
  • Patients with a history of ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina within the last 6 months
  • Patients with active bleeding
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  • Patients with major bleeding of the gastrointestinal or urinary system within the last 3 months
  • Patients with coagulation disorders prone to bleeding (including heparin-induced thrombocytopenia)
  • Patients with hypersensitivity to or contraindications to the following drugs: Heparin, Aspirin, Clopidogrel, Prasugrel, Contrast media (Patients sensitive to contrast media are not excluded if the condition can be effectively prevented through pretreatment with steroids or diphenhydramine (e.g., flare-ups).
  • Patients for whom percutaneous coronary intervention (PCI) is contraindicated
  • Patients who have already undergone coronary artery bypass grafting (CABG)
  • Patients with in-stent restenosis in the target lesion
  • Patients with chronic total occlusion (CTO) in major coronary arteries
  • Patients with lesions having an FFR of less than 0.64
  • Patients with coronary arteries that are anatomically unsuitable for both PCI and CABG
  • Patients with non-ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy
  • Patients with severe valvular disease or those judged by the investigator to be likely to require valve surgery or percutaneous valve replacement during the study period
  • Patients with non-cardiac diseases, etc., with a life expectancy of less than one year or expected to have low treatment adherence (at the investigator's judgment)
  • Pregnant or breastfeeding patients
  • Other patients deemed by the investigator to be unsuitable for participation in the clinical trial
  • Additional Criteria for nested RCT Studies
  • Significant bradycardia at rest, second-degree or higher atrioventricular block, or significant conduction disturbance
  • Bronchial asthma or clinically significant bronchospasmodic disease
  • Symptomatic hypotension
  • Variant angina as a main presentation
  • Other cases where the supervising investigator deems the use of beta-blockers medically inappropriate

Trial locations and contacts

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

Jung-Kyu Han, MD, PhD contact

+82-2-2072-4870

hpcrates@gmail.com

20 sites in 1 country

South Korea20 sites

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, 14068

    Sang Ho Jo, MD, PhD, 821032602227, sophi5neo@gmail.com

  • Bucheon Sejong Hospital

    Bucheon-si, Gyeonggi-do, 14754

    Ha Wook Park, MD, PhD, 821047571090, mrcmc@catholic.ac.kr

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Dong-Kie Kim, MD, PhD, 82-10-4595-9515, imnpymd@gmail.com

  • Pusan National University Hospital

    Busan, 49241

    Han Cheol Lee, MD, PhD, 821085574665, glaraone@hanmail.net

  • Kosin University Gospel Hospital

    Busan, 49267

    Jeong Ho Heo, MD, PhD, 821025012896, duggymdc@gmail.com

  • Samsung Changwon Medical Center

    Changwon, Gyeongsangnam-do, 51353

    Seung do Lee, MD, PhD, 82-10-5058-0483, lsd0483@gmail.com

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289

    Yong Hoon Kim, MD, PhD, 821022797515, yhkim02@kangwon.ac.kr

  • Keimyung University Dongsan Hospital

    Daegu, 41931

    Yun-Kyeong Cho, MD, PhD, 821085799423, ds010042@gmail.com

  • Kyungpook National University Hospital

    Daegu, 41944

    Janghoon Lee, MD, PhD, 82-53-200-6414, ljhmh75@knu.ac.kr

  • The Catholic University of Korea Daejeon St. Mary's Hospital

    Daejeon, 34943

    Kyusup Lee, MD, PhD, 821090590389, ajobi7121@gmail.com

  • Chungnam National University Hospital

    Daejeon, 35015

    Hyun-Woong Park, MD, PhD, 821052925459, chunjium@hanmail.net

  • GangNeung Asan Hospital

    Gangneung, Gangwon-do, 25440

    Han bit Park, MD, PhD, 821086666064, phb8012@gmail.com

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380

    Sung Woo Cho, MD, PhD, 821036676875, drswcho@hanmail.net

  • Chungnam National University Hospital

    Gwangju, 61469

    Min Chul Kim, MD, PhD, 821046062643, kmc3242@hanmail.net

  • Jeju National University Hospital

    Jeju City, 63241

    Song-Yi Kim, MD, PhD, 8214062714946, ttoromom@jejunu.ac.kr

  • Kangdong Sacred Heart Hospital

    Seoul, 05355

    Jun-Hee Lee, MD, PhD, 821025159234, ljhmong@naver.com

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

    Sang Hyun Kim, MD, PhD, 821071432533, shkimcarstudy@gmail.com

  • Ewha Womans University Medical Center

    Seoul, 07804

    Sang hoon Shin, MD, PhD, 821089610707, shin_sh@i.ewha.ac.kr

  • Koera University Guro Hospital

    Seoul, 08308

    Dong Oh Kang, MD, PhD, 821091486979, gelly9@naver.com

  • Ulsan Univeristy Hospital

    Ulsan, 44033

    Eun Seok Shin, MD, PhD, 821063194025, sesim1989@gmail.com

Other trials in South Korea

About this study

Official title: Percutaneous Intervention Versus Optimal Medical Therapy in Chronic Coronary Syndrome (PIVOT) Trial

Comparison of the incidence of major cardiovascular events between the combination of percutaneous intervention and optimal drug therapy and the optimal drug therapy alone in patients with chronic coronary syndrome.

  • Main RCT (Randomized Clinical Trial): Patients with chronic coronary syndrome enrolled in the study will be randomized in a 1:1 ratio to either 1) PCI(Percutaneous Coronary Intervention) plus optimal medical therapy or 2) optimal medical therapy alone, with clinical outcomes assessed during follow-up. (2,301 participants)
  • Nested RCT: An embedded randomized supplementary study was conducted on a subset (220 participants) of the total subjects.

In patients who have decided to use beta-blockers for the control of angina, additional 1:1 randomization evaluates the efficacy of carvedilol sustained-release (SR) and immediate-release (IR) formulations. Both formulations are targeted for use up to the maximal tolerated dose, taking into account patient symptoms.

Read the detailed description

Background:

In patients with chronic coronary syndrome (CCS), the role of percutaneous coronary intervention (PCI) beyond symptom relief - particularly in preventing future major cardiovascular events - remains an area of active debate. Landmark trials such as COURAGE and ISCHEMIA raised questions about the incremental benefit of PCI over optimal medical therapy (OMT) alone; however, both trials allowed crossover from the medical arm to PCI, and included periprocedural myocardial infarction (MI) in their primary endpoints, which may have diluted the observed treatment effects. Moreover, since those trials were conducted, both PCI techniques and pharmacological therapies have advanced substantially. Imaging-guided PCI using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) has been shown to reduce adverse cardiac events, and lipid-lowering strategies have been further strengthened by the addition of ezetimibe and PCSK9 inhibitors. Against this background, a rigorous re-evaluation of PCI's role in CCS, using contemporary devices and a more conservative definition of clinically driven revascularization, is warranted.

Study Design:

The PIVOT trial is a multicenter, prospective, open-label, randomized controlled trial conducted at multiple sites in South Korea. Eligible patients with CCS who have a functionally or anatomically significant coronary stenosis confirmed by coronary angiography are randomized 1:1 to either (1) PCI plus optimal medical therapy or (2) optimal medical therapy alone. Randomization is stratified by participating center and sex using a web-based system managed independently by the Medical Research Collaborating Center (MRCC).

Main RCT - Intervention:

In the PCI arm, the target lesion(s) are treated with drug-eluting stent(s) according to each site's standard practice. Imaging-guided PCI with IVUS or OCT is strongly recommended and is mandatory for complex PCI cases. The BioFreedom ULTRA stent (polymer-free, Biolimus A9-coated) is used preferentially; other approved drug-eluting stents may be used when clinically indicated. Following PCI, dual antiplatelet therapy is maintained for 6 months per guideline recommendation, with adjustments permissible based on individual bleeding and ischemic risk. Both arms receive guideline-directed optimal medical therapy, including intensive lipid-lowering treatment (LDL-C target <55 mg/dL), antiplatelet agents, and anti-anginal medications as indicated. Lifestyle interventions (smoking cessation, weight management, dietary modification, and physical activity) are also recommended.

Primary Endpoint (Main RCT):

Patient-oriented composite outcome (POCO): a composite of cardiovascular death, non-fatal myocardial infarction, or clinically driven revascularization at 2 years after completion of enrollment. Periprocedural MI is excluded from the primary endpoint. The trial is powered for superiority (one-sided α = 0.025, power = 90%), assuming a 2-year POCO rate of 12.0% in the OMT arm and 8.5% in the PCI arm. A total of 2,301 participants are required.

Follow-up:

Participants are followed at 6 months, 1, 2, 3, 4, and 5 years after enrollment (±90 days). Clinical outcomes, vital signs, laboratory tests, concomitant medications, and angina-related quality of life (Seattle Angina Questionnaire-7, SAQ-7) are assessed at every visit. Long-term follow-up up to 5 years after the last enrolled patient is planned to evaluate durability of treatment effects.

Nested RCT - Design and Rationale:

An embedded, independently randomized substudy (Nested RCT) is conducted within the PIVOT trial. Among participants in the main trial for whom beta-blocker therapy is deemed clinically appropriate - based on pre-specified criteria including heart rate control needs, history of prior MI, concurrent hypertension, tachyarrhythmia, or intolerance to calcium channel blockers - an additional 1:1 randomization is performed to compare carvedilol sustained-release (SR) versus immediate-release (IR) formulations. This substudy addresses the evidence gap regarding whether the two formulations are clinically equivalent in terms of angina symptom control in CCS patients, as head-to-head randomized data are currently lacking despite both being widely prescribed.

Nested RCT - Intervention:

Participants assigned to the SR arm receive carvedilol SR (Dilatrend SR; starting dose 32 mg once daily, up-titrated to 64 mg or 128 mg as tolerated). Participants assigned to the IR arm receive carvedilol IR (Dilatrend; starting dose 12.5 mg twice daily, up-titrated to 25 mg twice daily or 50 mg twice daily as tolerated). Both formulations are titrated to the maximal tolerated dose with a resting heart rate target of 55-60 bpm. Medication adherence is assessed by pill count at 6 and 12 months.

Primary Endpoint (Nested RCT):

Change in SAQ-7 Summary score from baseline to 12 months. Non-inferiority of carvedilol SR versus IR is concluded if the lower bound of the 95% confidence interval for the between-group difference exceeds -5 points, analyzed by ANCOVA adjusting for baseline SAQ-7 score. A total of 220 participants are required (one-sided α = 0.025, power = 80%, non-inferiority margin Δ = 5 points).

Statistical Analysis:

For the main RCT, the primary endpoint is analyzed using the Kaplan-Meier method with a stratified log-rank test in the intention-to-treat (ITT) population. Secondary time-to-event endpoints are analyzed using the cumulative incidence function with a Fine and Gray model, treating death as a competing risk. The Nested RCT primary endpoint is analyzed by ANCOVA in both the ITT and per-protocol (PP) populations.

Being tested
percutaneous coronary intervention, Guideline-directed Optimal Medical treatment, Carvedilol Sustained-Release (SR) (Nested RCT subset), Carvedilol Immediate-Release (IR) (Nested RCT subset)
Keywords
chronic coronary syndrome, percutaneous coronary intervention, optimal medical therapy

What participants receive

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

  • percutaneous coronary interventionProcedure or surgery

    PCI will be performed in addition to optimal medical therapy.

  • Guideline-directed Optimal Medical treatmentDrug

    Guideline-directed optimal medical therapy alone without PCI

  • Carvedilol Sustained-Release (SR) (Nested RCT subset)Drug

    Carvedilol SR (Dilatrend SR; 8/16/32/64 mg) once daily, starting at 32 mg and up-titrated to maximal tolerated dose (up to 128 mg). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.

  • Carvedilol Immediate-Release (IR) (Nested RCT subset)Drug

    Carvedilol IR (Dilatrend; 3.125/6.25/12.5/25 mg) twice daily, starting at 12.5 mg BID and up-titrated to maximal tolerated dose (up to 50 mg BID). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.

Study groups in NCT07577518
Study groupRoleWhat they receive
PCIExperimentalPCI will be performed in addition to guideline-directed optimal medical therapy
Receives: Procedure: percutaneous coronary intervention; Drug: Guideline-directed Optimal Medical treatment; Drug: Carvedilol Sustained-Release (SR) (Nested RCT subset); Drug: Carvedilol Immediate-Release (IR) (Nested RCT subset)
Guideline-directed Optimal Medical treatmentActive comparatorOptimal medical therapy alone without PCI
Receives: Drug: Guideline-directed Optimal Medical treatment; Drug: Carvedilol Sustained-Release (SR) (Nested RCT subset); Drug: Carvedilol Immediate-Release (IR) (Nested RCT subset)

What is being measured

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

  1. Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization

    This outcome applies to the main RCT (n=2,301). POCO is a composite of three components: (1) cardiovascular death; (2) non-fatal myocardial infarction, excluding periprocedural MI; and (3) clinically driven revascularization. The first occurrence of any component is counted as the primary event per participant.

    Clinically driven revascularization is defined as revascularization of a coronary segment with diameter stenosis ≥50% by quantitative coronary angiography, accompanied by at least one of the following: ischemic ECG(Electrocardiogram) changes at rest; typical ischemic symptoms refractory to medical therapy; unstable angina; positive invasive physiologic test (FFR(Fractional Flow Reserve) ≤0.80 or iFR (Instantaneous Wave-Free Ratio) ≤0.89); or angiographic progression with diameter stenosis ≥70% by quantitative coronary angiography regardless of other criteria.

    Measured: 2nd year and 5th year since registration was complete

  2. Change in Seattle Angina Questionnaire-7 (SAQ-7) Summary Score from Baseline to 12 Months (for Nested RCT)

    This outcome applies to the Nested RCT substudy only (n=220), in which participants eligible for beta-blocker therapy are independently randomized 1:1 to carvedilol SR or IR, regardless of their main trial allocation. The SAQ-7 is a 7-item validated questionnaire assessing angina-related health status across three domains: physical limitation, angina frequency, and quality of life. Scores range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ-7 Summary score is calculated as the mean of the three domain scores.

    Measured: One year after registration

Secondary outcomes (15)

  1. Number of Participants with All-cause death

    Measured: 2nd year and 5th year since registration was complete

  2. Number of Participants with Cardiovascular death

    Measured: 2nd year and 5th year since registration was complete

  3. Number of Participants with Cardiovascular Death or Non-Fatal Myocardial Infarction

    Measured: 2nd year and 5th year since registration was complete

  4. Number of Participants with Myocardial Infarction

    Measured: 2nd year and 5th year since registration was complete

  5. Number of Participants with Spontaneous myocardial infarction

    Measured: 2nd year and 5th year since registration was complete

  6. Number of Participants with Periprocedural myocardial infarction

    Measured: 2nd year and 5th year since registration was complete

  7. Number of Participants with Periprocedural myocardial infarction, as defined by the Fourth Universal Definition of Myocardial Infarction

    Measured: 2nd year and 5th year since registration was complete

  8. Number of Participants with Ischemic stroke

    Measured: 2nd year and 5th year since registration was complete

  9. Number of Participants with Stent thrombosis

    Measured: 2nd year and 5th year since registration was complete

  10. Number of Participants with Transient ischemic attack

    Measured: 2nd year and 5th year since registration was complete

  11. Number of Participants with Clinically driven revascularization

    Measured: 2nd year and 5th year since registration was complete

  12. Number of Participants with any revascularization

    Measured: 2nd year and 5th year since registration was complete

  13. Number of Participants with ischemia driven revascularization

    Measured: 2nd year and 5th year since registration was complete

  14. Number of Participants with Major bleeding events

    BARC(Bleeding Academic Research Consortium) classification, type 3 or 5

    Measured: 2nd year and 5th year since registration was complete

  15. Number of Participants with Clinically relevant non-major bleeding events

    BARC(Bleeding Academic Research Consortium) classification, type 2

    Measured: 2nd year and 5th year since registration was complete

Timeline

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

  1. First posted11 May 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion27 Apr 2030 (estimated)
  4. Study completion10 Mar 2034 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,301 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577518
Sponsor's protocol ID
H-2601-092-1709
Acronym
PIVOT
Status last verified
Jun 2026
First submitted
4 May 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chan PS, Jones PG, Arnold SA, Spertus JA. Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):640-7. doi: 10.1161/CIRCOUTCOMES.114.000967. Epub 2014 Sep 2.

    PubMed 25185249

  • Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.

    PubMed 30158069

  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PubMed 22890468

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PubMed 21670242

  • Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

    PubMed 29891620

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

    PubMed 30571511

  • Jang Y, Park SD, Lee JP, Choi SH, Kong MG, Won YS, Kim M, Lee KH, Han SH, Kwon SW, Suh J, Kang WC. One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial. EuroIntervention. 2025 Jul 21;21(14):e796-e809. doi: 10.4244/EIJ-D-25-00331.

    PubMed 40392195

  • Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.

    PubMed 26466021

  • Hu X, Zhang J, Yang S, Jiang J, Peng X, Lu D, Pan Y, Guo L, Li J, He W, Zhou H, Pu J, Huang J, Jiang F, Liu Q, Song D, Lu L, Cheng Z, Yang B, Ma J, Chen P, Li S, Meng Z, Tang L, Fan Y, Shin ES, Tu S, Nam CW, Fearon WF, Koo BK, Wang J; FLAVOUR II study group. Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial. Lancet. 2025 Apr 26;405(10488):1491-1504. doi: 10.1016/S0140-6736(25)00504-5. Epub 2025 Mar 30.

    PubMed 40174597

  • Ahn JM, Park SJ. Response by Ahn and Park to Letter Regarding Article, "Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease: Data From a Prospective IRIS-FFR Registry (Interventional Cardiology Research Incooperation Society Fractional Flow Reserve)". Circulation. 2017 Dec 12;136(24):2393-2394. doi: 10.1161/CIRCULATIONAHA.117.030994. No abstract available.

    PubMed 29229624

  • Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.

    PubMed 25323250

  • Williams MC, Wereski R, Tuck C, Adamson PD, Shah ASV, van Beek EJR, Roditi G, Berry C, Boon N, Flather M, Lewis S, Norrie J, Timmis AD, Mills NL, Dweck MR, Newby DE; SCOT-HEART Investigators. Coronary CT angiography-guided management of patients with stable chest pain: 10-year outcomes from the SCOT-HEART randomised controlled trial in Scotland. Lancet. 2025 Jan 25;405(10475):329-337. doi: 10.1016/S0140-6736(24)02679-5.

    PubMed 39863372

  • Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.

    PubMed 37634149

  • Zhang J, Gao X, Kan J, Ge Z, Han L, Lu S, Tian N, Lin S, Lu Q, Wu X, Li Q, Liu Z, Chen Y, Qian X, Wang J, Chai D, Chen C, Li X, Gogas BD, Pan T, Shan S, Ye F, Chen SL. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013. Epub 2018 Sep 24.

    PubMed 30261237

  • Hong SJ, Lee SJ, Lee SH, Lee JY, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Kim SJ, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; OCCUPI investigators. Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea. Lancet. 2024 Sep 14;404(10457):1029-1039. doi: 10.1016/S0140-6736(24)01454-5. Epub 2024 Sep 2.

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Questions about this trial

What is this clinical trial studying?

A study testing percutaneous coronary intervention, Guideline-directed Optimal Medical treatment and Carvedilol Sustained-Release (SR) (Nested RCT subset) in people with Chronic Coronary Syndrome, run by Seoul National University Hospital at 20 sites 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 15 inclusion and 26 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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.

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 Jung-Kyu Han, MD, PhD (+82-2-2072-4870, hpcrates@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization (time frame: 2nd year and 5th year since registration was complete). 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 NCT07577518, which also lists 28 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 12 Jun 2026.

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