Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)
NCT ID: NCT05845489
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
11086 participants
INTERVENTIONAL
2023-03-22
2031-12-31
Brief Summary
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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.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Clopidogrel treatment group
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
Clopidogrel treatment group
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
No antiplatelet or anticoagulant group
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.
No antiplatelet or anticoagulant group
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.
Interventions
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Clopidogrel treatment group
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
No antiplatelet or anticoagulant group
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Samjin Pharmaceutical Co., Ltd.
INDUSTRY
CKD Pharmaceutical Limited
UNKNOWN
Hanmi Pharmaceutical co., ltd.
OTHER
Yuhan Pharmaceutical Company
UNKNOWN
Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Dong-A ST Co., Ltd.
INDUSTRY
IlDong Pharmaceutical Co Ltd
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Hyo-Soo Kim
Professor
Principal Investigators
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Hyo-Soo Kim, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Other, South Korea
Andong Hospital
Andong, , South Korea
Dong-A University Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Eulji University Hospital, Daejeon
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Kwangju Christian Hospital
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, , South Korea
Eulji University Hospital, Uijeongbu
Gyeonggi-do, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, , South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, , South Korea
Inje University Ilsan Paik Hospital
Gyeonggi-do, , South Korea
Myongji Hospital
Gyeonggi-do, , South Korea
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, , South Korea
Sejong General Hospital, Bucheon
Gyeonggi-do, , South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, , South Korea
Yonsei University Yongin Severance Hospital
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Catholic Kwandong University International St. Mary's Hospital
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Jesus Hospital, Jeonju
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Pohang Stroke And Spine Hospital
Pohang, , South Korea
Chungnam National University Sejong Hospital
Sejong, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Veterans Health Service Medical Center
Seoul, , South Korea
Yonsei University Gangnam Severance Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jung-Kyu Han, MD, PhD
Role: primary
Joong Kyung Sung, MD,PhD
Role: primary
Tae-Ho Park, MD,PhD
Role: primary
Tae-Hyun Yang, MD,PhD
Role: primary
Jeong Ho Heo
Role: primary
Han Cheol Lee, MD,PhD
Role: primary
Jong Hwa Ahn, MD,PhD
Role: primary
Sang Ho Park, MD,PhD
Role: primary
Won Yong Shin, MD,PhD
Role: primary
Seung Jin Lee, MD,PhD
Role: primary
Kyung-Kuk Hwang, MD,PhD
Role: primary
Hyun-Hee Choi, MD,PhD
Role: primary
Yong HOON Kim, MD,PhD
Role: primary
Bong-Ki Lee, MD,PhD
Role: primary
Hyuck Jun Yoon, MD,PhD
Role: primary
Jong Seon Park, MD,PhD
Role: primary
Hyun-Woong Park, MD,PhD
Role: primary
Kyu-Sun Lee, MD,PhD
Role: primary
Hanbit Park, MD,PhD
Role: primary
Ju Han kim, MD,PhD
Role: primary
Young Joon Hong, MD,PhD
Role: primary
SEUNG UK LEE, MD,PhD
Role: primary
Young Hoon Jeong, MD,PhD
Role: primary
Jung Yeon Chin, MD,PhD
Role: primary
Dae Young Cheon, MD,PhD
Role: primary
Sang Ho Jo, MD,PhD
Role: primary
Joon-Hyung Doh, MD,PhD
Role: primary
Yun-Hyeong Cho, MD,PhD
Role: primary
Ji-Yong Jang, MD,PhD
Role: primary
Young Jin Choi, MD,PhD
Role: primary
YOON HAENG CHO, MD,PhD
Role: primary
Deok-Kyu Cho, MD,PhD
Role: primary
Ju Han kim, MD,PhD
Role: primary
Hyung-bok Park, MD,PhD
Role: primary
Seung Hwan Han, MD,PhD
Role: primary
Song-Yi Kim, MD,PhD
Role: primary
Jong-Pil Park, MD,PhD
Role: primary
Min Gyu Kang, MD,PhD
Role: primary
Yong-Suk Jeong, MD,PhD
Role: primary
Wonmook Hwang, MD,PhD
Role: primary
KWANG JE LEE, MD,PhD
Role: primary
Kyung Taek Park, MD,PhD
Role: primary
Choongki Kim, MD,PhD
Role: primary
Sanghoon Shin, MD,PhD
Role: primary
KyooRok HAN, MD,PhD
Role: primary
Jun-Hee Lee, MD,PhD
Role: primary
Namho Lee, MD,PhD
Role: primary
Young Hyo Lim, MD,PhD
Role: primary
Young Sup Byun, MD,PhD
Role: primary
Byung Jin Kim, MD,PhD
Role: primary
soon jun Hong, MD,PhD
Role: primary
Seung-Woon Rha, MD,PhD
Role: primary
Weon Kim, MD,PhD
Role: primary
Joo-Yong Hahn, MD,PhD
Role: primary
Joo Ho Lee, MD,PhD
Role: primary
SANG HYUN KIM, MD,PhD
Role: primary
duk won Bang, MD,PhD
Role: primary
changhoon Lee, MD,PhD
Role: primary
Byoung Kwon Lee, MD,PhD
Role: primary
Eun Seok Shin, MD,PhD
Role: primary
Sung Gyun AHN, MD,PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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H-2212-044-1385
Identifier Type: -
Identifier Source: org_study_id