Coronary Artery DiseasePhase 4NCT05845489

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)

A Phase 4 study testing Clopidogrel treatment group and No antiplatelet or anticoagulant group in people with Coronary Artery Disease, run by Seoul National University Hospital at 61 sites 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

The investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Clopidogrel treatment group and No antiplatelet or anticoagulant group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11,086 participants
Where: 61 sitesSouth Korea
Study dates: 22 Mar 2023to 31 Dec 2031
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged ≥40 years
Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study
Without significant coronary artery stenosis (Diameter stenosis >50%), which needs revascularization
Agreement to give written informed consent

Who cannot join

A history of a diagnosed cardiovascular or cerebrovascular disease (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis>50%, carotid artery intervention)
A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy
Absolute contraindication or allergy to clopidogrel
Patients receiving anticoagulants for other comorbidities
A history of Bleeding diathesis, known coagulopathy, or major bleeding, BARC class ≥3, resulting in the stop of antiplatelet agents
Planned surgery or intervention which needs to stop antiplatelet agents ≥1 month

Show all 9Show fewer

Presence of non-cardiac comorbidity with life expectancy ≤ 5 years at randomization
Females with pregnancy or breast-feeding
Patients who are thought to be inappropriate for the trial based on physicians' decision

Trial locations and contacts

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

Jung-Kyu Han, MD, PhD contact

821026765736

hpcrates@gmail.com

City, postcode or hospital

Sites recruiting now only

61 sites in 1 country

South Korea61 sites, 61 recruiting

Andong Hospital
Andong
Joong Kyung Sung, MD,PhD, +82-10-4212-9294, sjkaa@hanmail.net
Recruiting
Dong-A University Hospital
Busan
Tae-Ho Park, MD,PhD, +82-10-2616-1713, thpark65@dau.ac.kr
Recruiting
Inje University Busan Paik Hospital
Busan
Tae-Hyun Yang, MD,PhD, +82-10-4590-5067, yangthmd@naver.com
Recruiting
Kosin University Gospel Hospital
Busan
Jeong Ho Heo, +82-10-2501-2896, duggymdc@gmail.com
Recruiting
Pusan National University Hospital
Busan
Han Cheol Lee, MD,PhD, +82-10-8557-4665, glaraone@hanmail.net
Recruiting
Gyeongsang National University Changwon Hospital
Changwon
Jong Hwa Ahn, MD,PhD, +82-10-7138-5232, jonghwaahn@naver.com
Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan
Sang Ho Park, MD,PhD, +82-10-5662-4500, matsalong@schmc.ac.kr
Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan
Won Yong Shin, MD,PhD, +82-10-6705-2120, shinwy@schmc.ac.kr
Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan
Seung Jin Lee, MD,PhD, +82-10-6705-2120, shinwy@schmc.ac.kr
Recruiting
Chungbuk National University Hospital
Cheongju-si
Kyung-Kuk Hwang, MD,PhD, +82-10-2250-8940, kyungkukhwang@gmail.com
Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
Hyun-Hee Choi, MD,PhD, +82-10-4740-2511, jumdure@hanmail.net
Recruiting
Kangwon National University Hospital
Chuncheon
Yong HOON Kim, MD,PhD, +82-10-2279-7515, yhkim02@kangwon.ac.kr
Recruiting
Kangwon National University Hospital
Chuncheon
Bong-Ki Lee, MD,PhD, +82-10-6373-9290, nicedr1969@gmail.com
Recruiting
Keimyung University Dongsan Hospital
Daegu
Hyuck Jun Yoon, MD,PhD, +82-10-2501-9351, hippsons@gmail.com
Recruiting
Yeungnam University Medical Center
Daegu
Jong Seon Park, MD,PhD, +82-10-3156-0149, pjs@med.yu.ac.kr
Recruiting
Chungnam National University Hospital
Daejeon
Hyun-Woong Park, MD,PhD, +82-10-5292-5459, chunjium@hanmail.net
Recruiting
Eulji University Hospital, Daejeon
Daejeon
Kyu-Sun Lee, MD,PhD, +82-10-3918-8929, leekyusun78@gmail.com
Recruiting
Gangneung Asan Hospital
Gangneung
Hanbit Park, MD,PhD, +82-10-8666-6064, phb8012@gmail.com
Recruiting
Chonnam National University Hospital
Gwangju
Ju Han kim, MD,PhD, +82-10-3629-0220, kim@zuhan.com
Recruiting
Chonnam National University Hospital
Gwangju
Young Joon Hong, MD,PhD, +82-10-2055-7919, hyj200@hanmail.net
Recruiting
Kwangju Christian Hospital
Gwangju
SEUNG UK LEE, MD,PhD, +82-10-3110-2974, cardiosu@hanmail.net
Recruiting
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do
Young Hoon Jeong, MD,PhD, +82-10-7343-4670, goodoctor@naver.com
Recruiting
Eulji University Hospital, Uijeongbu
Gyeonggi-do
Jung Yeon Chin, MD,PhD, +82-10-3446-0201, 20150046@eulji.ac.kr
Recruiting
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Dae Young Cheon, MD,PhD, +82-10-3766-0504, arkad86@hanmail.net
Recruiting
Hallym University Sacred Heart Hospital
Gyeonggi-do
Sang Ho Jo, MD,PhD, +82-10-3260-2227, sophi5neo@gmail.com
Recruiting
Inje University Ilsan Paik Hospital
Gyeonggi-do
Joon-Hyung Doh, MD,PhD, +82-10-9610-1570, djh95@paik.ac
Recruiting
Myongji Hospital
Gyeonggi-do
Yun-Hyeong Cho, MD,PhD, +82-10-8865-0232, princette@hanmail.net
Recruiting
National Health Insurance Service Ilsan Hospital
Gyeonggi-do
Ji-Yong Jang, MD,PhD, +82-10-4339-3918, dogkkoma@gmail.com
Recruiting
Sejong General Hospital, Bucheon
Gyeonggi-do
Young Jin Choi, MD,PhD, +82-10-6228-8623, cyjheart@gmail.com
Recruiting
Soonchunhyang University Bucheon Hospital
Gyeonggi-do
YOON HAENG CHO, MD,PhD, +82-10-5312-2129, yhcho@schmc.ac.kr
Recruiting
Yonsei University Yongin Severance Hospital
Gyeonggi-do
Deok-Kyu Cho, MD,PhD, +82-10-2037-9787, chodk1234@daum.net
Recruiting
Chonnam National University Hwasun Hospital
Hwasun
Ju Han kim, MD,PhD, +82-10-3629-0220, kim@zuhan.com
Recruiting
Catholic Kwandong University International St. Mary's Hospital
Incheon
Hyung-bok Park, MD,PhD, +82-10-6855-0456, hyungbok7@naver.com
Recruiting
Gachon University Gil Medical Center
Incheon
Seung Hwan Han, MD,PhD, +8210-7795-5671, kheartist@gmail.com
Recruiting
Jeju National University Hospital
Jeju City
Song-Yi Kim, MD,PhD, +82-10-6271-4946, ttoromom@jejunu.ac.kr
Recruiting
Jesus Hospital, Jeonju
Jeonju
Jong-Pil Park, MD,PhD, +82-10-7445-6619, jppark74@gmail.com
Recruiting
Gyeongsang National University Hospital
Jinju
Min Gyu Kang, MD,PhD, +82-10-3568-4113, med2floyd@naver.com
Recruiting
Pohang Stroke And Spine Hospital
Pohang
Yong-Suk Jeong, MD,PhD, +82-10-7527-9008, lukejungmd@hanmail.net
Recruiting
Chungnam National University Sejong Hospital
Sejong
Wonmook Hwang, MD,PhD, +82-10-2516-5917, pascalline@hanmail.net
Recruiting
Seoul National University Hospital
Seoul, Other, 03080
Jung-Kyu Han, MD, PhD, 82220724870, hpcrates@gmail.com
Recruiting
Chung-Ang University Hospital
Seoul
KWANG JE LEE, MD,PhD, +82-10-6226-6165, heartlee@cau.ac.kr
Recruiting
Chung-Ang University Hospital
Seoul
Kyung Taek Park, MD,PhD, +82-10-3785-3106, parkkt@cauhs.or.kr
Recruiting
Ewha Womans University Seoul Hospital
Seoul
Choongki Kim, MD,PhD, +82-10-2071-4382, splennov26@gmail.com
Recruiting
Ewha Womans University Seoul Hospital
Seoul
Sanghoon Shin, MD,PhD, +82-10-8961-0707, shin_sh@i.ewha.ac.kr
Recruiting
Hallym University Kangdong Sacred Heart Hospital
Seoul
KyooRok HAN, MD,PhD, +82-10-9397-5252, krheart@kdh.or.kr
Recruiting
Hallym University Kangdong Sacred Heart Hospital
Seoul
Jun-Hee Lee, MD,PhD, +82-10-2515-9234, ljhmong@naver.com
Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul
Namho Lee, MD,PhD, +82-10-5849-7787, namholee@hanmail.net
Recruiting
Hanyang University Hospital
Seoul
Young Hyo Lim, MD,PhD, +82-10-6769-8762, mdoim@hanyang.ac.kr
Recruiting
Inje University Sanggye Paik Hospital
Seoul
Young Sup Byun, MD,PhD, +82-10-6225-6579, bbbyun@gmail.com
Recruiting
Kangbuk Samsung Hospital
Seoul
Byung Jin Kim, MD,PhD, +82-10-2663-6943, bjjake.kim@gmail.com
Recruiting
Korea University Anam Hospital
Seoul
soon jun Hong, MD,PhD, +82-10-3485-1379, psyche94@hanmail.net
Recruiting
Korea University Guro Hospital
Seoul
Seung-Woon Rha, MD,PhD, +82-10-8721-0459, swrha6172@naver.com
Recruiting
Kyung Hee University Hospital
Seoul
Weon Kim, MD,PhD, +82-10-3610-6172, mylovekw@hanmail.net
Recruiting
Samsung Medical Center
Seoul
Joo-Yong Hahn, MD,PhD, +82-10-9933-5070, jooyong.hahn@gmail.com
Recruiting
Seoul Medical Center
Seoul
Joo Ho Lee, MD,PhD, +82-10-6852-7716, needyjh@daum.net
Recruiting
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul
SANG HYUN KIM, MD,PhD, +82-10-7143-2533, shkimcarstudy@gmail.com
Recruiting
Soonchunhyang University Seoul Hospital
Seoul
duk won Bang, MD,PhD, +82-10-4105-9440, schbdw@schmc.ac.kr
Recruiting
Veterans Health Service Medical Center
Seoul
changhoon Lee, MD,PhD, +82-10-5551-7867, zekilee@hanmail.net
Recruiting
Yonsei University Gangnam Severance Hospital
Seoul
Byoung Kwon Lee, MD,PhD, +82-10-2721-8813, CARDIOBK@yuhs.ac
Recruiting
Ulsan University Hospital
Ulsan
Eun Seok Shin, MD,PhD, +82-10-6319-4025, sesim1989@gmail.com
Recruiting
Yonsei University Wonju Severance Christian Hospital
Wŏnju
Sung Gyun AHN, MD,PhD, +82-10-8245-9091, sgahn@yonsei.ac.kr
Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging

The trial will test the hypothesis that clopidogrel is beneficial in preventing major adverse cardiovascular and cerebrovascular events (MACCE) in patients with subclinical coronary atherosclerosis identified on imaging.

Read the detailed description

Coronary artery disease (CAD) is the most prevalent and lethal disease worldwide. Even though various studies have been performed regarding the prevention or treatment of CAD and its related cardiovascular events, the prevalence of CAD and the incidence of cardiovascular events are increasing.

Antiplatelet agents are among the most widely used drugs for preventing cardiovascular events. The efficacy of antiplatelet agents has been extensively proven in secondary prevention for cardiovascular events in CAD patients, and their use has been recommended in current guidelines. However, there is still controversy surrounding the prescription of antiplatelet agents for the primary prevention of cardiovascular events in CAD patients due to their unknown clear efficacy and risk of bleeding complications.

Recent studies reported the limited efficacy of aspirin in old patients, diabetes patients, or patients with cardiovascular events risks. However, the efficacy or safety of antiplatelet therapy in patients with subclinical coronary atherosclerosis has not been thoroughly investigated. These patients are at higher risk of cardiac death or myocardial infarction compared to patients without coronary atherosclerosis.

In this regard, the investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.

Conditions: Coronary Artery Disease
Being tested: Clopidogrel treatment group, No antiplatelet or anticoagulant group
Keywords: coronary artery disease, clopidogrel, prevention
Medical subject headings: Coronary Artery Disease

What participants receive

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

Clopidogrel treatment groupDrug
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
No antiplatelet or anticoagulant groupOther
Patients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.

Study groups in NCT05845489
Study group	Role	What they receive
Clopidogrel treatment group	Experimental	Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years. Receives: Drug: Clopidogrel treatment group
No antiplatelet or anticoagulant group	Active comparator	Patients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board. Receives: Other: No antiplatelet or anticoagulant group

What is being measured

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

Major adverse cardiovascular and cerebrovascular events (MACCE)
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack
Measured: at 2 years after the last enrollment

Secondary outcomes (11)

Major adverse cardiovascular and cerebrovascular events (MACCE)
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack
Measured: at 5 years after the last enrollment
Net adverse clinical event
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke or transient ischemic attack, major bleeding
Measured: at 2 years and 5 years after the last enrollment
All-cause death
Measured: at 2 years and 5 years after the last enrollment
Non-fatal myocardial infarction
Measured: at 2 years and 5 years after the last enrollment
Any coronary revascularization
Measured: at 2 years and 5 years after the last enrollment
Ischemic stroke or Transient ischemic attack
Measured: at 2 years and 5 years after the last enrollment
Any non-coronary revascularization
Measured: at 2 years and 5 years after the last enrollment
Major bleeding events
BARC classification, type 3 or 5
Measured: at 2 years and 5 years after the last enrollment
BARC type 2 bleeding events
Measured: at 2 years and 5 years after the last enrollment
BARC type 3 bleeding events
Measured: at 2 years and 5 years after the last enrollment
BARC type 5 bleeding events
Measured: at 2 years and 5 years after the last enrollment

Timeline

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

22 Mar 202331 Dec 2031

First posted6 May 2023
Study start22 Mar 2023
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11,086 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05845489
Sponsor's protocol ID: H-2212-044-1385
Status last verified: Dec 2025
First submitted: 25 Apr 2023
Last updated: 31 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yazdanyar A, Newman AB. The burden of cardiovascular disease in the elderly: morbidity, mortality, and costs. Clin Geriatr Med. 2009 Nov;25(4):563-77, vii. doi: 10.1016/j.cger.2009.07.007.
PubMed 19944261
Hennekens CH, Dyken ML, Fuster V. Aspirin as a therapeutic agent in cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1997 Oct 21;96(8):2751-3. doi: 10.1161/01.cir.96.8.2751. No abstract available.
PubMed 9355934
Ajani UA, Ford ES, Greenland KJ, Giles WH, Mokdad AH. Aspirin use among U.S. adults: Behavioral Risk Factor Surveillance System. Am J Prev Med. 2006 Jan;30(1):74-7. doi: 10.1016/j.amepre.2005.08.042.
PubMed 16414427
Ittaman SV, VanWormer JJ, Rezkalla SH. The role of aspirin in the prevention of cardiovascular disease. Clin Med Res. 2014 Dec;12(3-4):147-54. doi: 10.3121/cmr.2013.1197. Epub 2014 Feb 26.
PubMed 24573704
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PubMed 30165437
McNeil JJ, Wolfe R, Woods RL, Tonkin AM, Donnan GA, Nelson MR, Reid CM, Lockery JE, Kirpach B, Storey E, Shah RC, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Johnston CI, Ryan J, Radziszewska B, Jelinek M, Malik M, Eaton CB, Brauer D, Cloud G, Wood EM, Mahady SE, Satterfield S, Grimm R, Murray AM; ASPREE Investigator Group. Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1509-1518. doi: 10.1056/NEJMoa1805819. Epub 2018 Sep 16.
PubMed 30221597
ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539. doi: 10.1056/NEJMoa1804988. Epub 2018 Aug 26.
PubMed 30146931
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
Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
PubMed 30879355
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905
Habib PJ, Green J, Butterfield RC, Kuntz GM, Murthy R, Kraemer DF, Percy RF, Miller AB, Strom JA. Association of cardiac events with coronary artery disease detected by 64-slice or greater coronary CT angiography: a systematic review and meta-analysis. Int J Cardiol. 2013 Oct 30;169(2):112-20. doi: 10.1016/j.ijcard.2013.08.096. Epub 2013 Sep 7.
PubMed 24090745
Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
PubMed 34010616
Schlett CL, Banerji D, Siegel E, Bamberg F, Lehman SJ, Ferencik M, Brady TJ, Nagurney JT, Hoffmann U, Truong QA. Prognostic value of CT angiography for major adverse cardiac events in patients with acute chest pain from the emergency department: 2-year outcomes of the ROMICAT trial. JACC Cardiovasc Imaging. 2011 May;4(5):481-91. doi: 10.1016/j.jcmg.2010.12.008.
PubMed 21565735
de Azevedo CF, Hadlich MS, Bezerra SG, Petriz JL, Alves RR, de Souza O, Rati M, Albuquerque DC, Moll J. Prognostic value of CT angiography in patients with inconclusive functional stress tests. JACC Cardiovasc Imaging. 2011 Jul;4(7):740-51. doi: 10.1016/j.jcmg.2011.02.017.
PubMed 21757164

Interested in taking part?

Jung-Kyu Han, MD, PhD

821026765736

hpcrates@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
ClinicalTrials.gov ID: NCT05845489
Acronym / sponsor ID: H-2212-044-1385
Conditions: Coronary Artery Disease
Keywords: coronary artery disease, clopidogrel, prevention
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 11,086 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Samjin Pharmaceutical Co., Ltd., CKD Pharmaceutical Limited, Hanmi Pharmaceutical co., ltd., Yuhan Pharmaceutical Company, Daewoong Pharmaceutical Co. LTD., Dong-A ST Co., Ltd., IlDong Pharmaceutical Co Ltd
Study start: 22 Mar 2023 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2031 (estimated)
First posted: 6 May 2023 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clopidogrel treatment group	Experimental	Drug: Clopidogrel treatment groupPatients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
No antiplatelet or anticoagulant group	Active comparator	Other: No antiplatelet or anticoagulant groupPatients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female aged ≥40 years
Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study
Without significant coronary artery stenosis (Diameter stenosis >50%), which needs revascularization
Agreement to give written informed consent

Key exclusion criteria (9 listed)

A history of a diagnosed cardiovascular or cerebrovascular disease (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis>50%, carotid artery intervention)
A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy
Absolute contraindication or allergy to clopidogrel
Patients receiving anticoagulants for other comorbidities
A history of Bleeding diathesis, known coagulopathy, or major bleeding, BARC class ≥3, resulting in the stop of antiplatelet agents

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
Clopidogrel treatment groupPatients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.	Drug	Clopidogrel treatment group
No antiplatelet or anticoagulant groupPatients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.	Other	No antiplatelet or anticoagulant group

Primary outcome

Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: at 2 years after the last enrollment
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack

11 secondary outcomes

Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: at 5 years after the last enrollment
Net adverse clinical event
Time frame: at 2 years and 5 years after the last enrollment
All-cause death
Time frame: at 2 years and 5 years after the last enrollment
Non-fatal myocardial infarction
Time frame: at 2 years and 5 years after the last enrollment
Any coronary revascularization
Time frame: at 2 years and 5 years after the last enrollment
Ischemic stroke or Transient ischemic attack
Time frame: at 2 years and 5 years after the last enrollment
Any non-coronary revascularization
Time frame: at 2 years and 5 years after the last enrollment
Major bleeding events
Time frame: at 2 years and 5 years after the last enrollment
BARC type 2 bleeding events
Time frame: at 2 years and 5 years after the last enrollment
BARC type 3 bleeding events
Time frame: at 2 years and 5 years after the last enrollment
BARC type 5 bleeding events
Time frame: at 2 years and 5 years after the last enrollment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
Background: PubMed 19944261Yazdanyar A, Newman AB. The burden of cardiovascular disease in the elderly: morbidity, mortality, and costs. Clin Geriatr Med. 2009 Nov;25(4):563-77, vii. doi: 10.1016/j.cger.2009.07.007.
Background: PubMed 9355934Hennekens CH, Dyken ML, Fuster V. Aspirin as a therapeutic agent in cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1997 Oct 21;96(8):2751-3. doi: 10.1161/01.cir.96.8.2751. No abstract available.
Background: PubMed 16414427Ajani UA, Ford ES, Greenland KJ, Giles WH, Mokdad AH. Aspirin use among U.S. adults: Behavioral Risk Factor Surveillance System. Am J Prev Med. 2006 Jan;30(1):74-7. doi: 10.1016/j.amepre.2005.08.042.
Background: PubMed 24573704Ittaman SV, VanWormer JJ, Rezkalla SH. The role of aspirin in the prevention of cardiovascular disease. Clin Med Res. 2014 Dec;12(3-4):147-54. doi: 10.3121/cmr.2013.1197. Epub 2014 Feb 26.
Background: PubMed 30165437Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
Background: PubMed 30221597McNeil JJ, Wolfe R, Woods RL, Tonkin AM, Donnan GA, Nelson MR, Reid CM, Lockery JE, Kirpach B, Storey E, Shah RC, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Johnston CI, Ryan J, Radziszewska B, Jelinek M, Malik M, Eaton CB, Brauer D, Cloud G, Wood EM, Mahady SE, Satterfield S, Grimm R, Murray AM; ASPREE Investigator Group. Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1509-1518. doi: 10.1056/NEJMoa1805819. Epub 2018 Sep 16.
Background: PubMed 30146931ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539. doi: 10.1056/NEJMoa1804988. Epub 2018 Aug 26.
Background: PubMed 30158069Gaziano 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.
Background: PubMed 30879355Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
Background: PubMed 24090745Habib PJ, Green J, Butterfield RC, Kuntz GM, Murthy R, Kraemer DF, Percy RF, Miller AB, Strom JA. Association of cardiac events with coronary artery disease detected by 64-slice or greater coronary CT angiography: a systematic review and meta-analysis. Int J Cardiol. 2013 Oct 30;169(2):112-20. doi: 10.1016/j.ijcard.2013.08.096. Epub 2013 Sep 7.
Background: PubMed 34010616Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
Individual participant dataSharing planned: No

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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.

Jung-Kyu Han, MD, PhD contact

821026765736

hpcrates@gmail.com

Hyo-Soo Kim, MD, PhD study chair

Seoul National University Hospital

61 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 9 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 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.

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 Jung-Kyu Han, MD, PhD (821026765736, hpcrates@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 and cerebrovascular events (MACCE) (time frame: at 2 years after the last enrollment). 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 NCT05845489, which also lists 14 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 31 Dec 2025.