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

NCT05845489 | Recruiting Phase 4 DMC

• 1 other identifier: H-2212-044-1385
• Study Type: interventional
• Target: 11,086
• Locations: 1 country
• Sites: 61

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; clopidogrel; prevention

Outcome Measures

Primary Outcomes (1)

• 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

  at 2 years after the last enrollment

Secondary Outcomes (11)

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  at 5 years after the last enrollment

• Net adverse clinical event

  at 2 years and 5 years after the last enrollment

• All-cause death

  at 2 years and 5 years after the last enrollment

• Non-fatal myocardial infarction

  at 2 years and 5 years after the last enrollment

• Any coronary revascularization

  at 2 years and 5 years after the last enrollment

Study Arms (2)

Clopidogrel treatment group

EXPERIMENTAL

Patients 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 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.

Other: No antiplatelet or anticoagulant group

Interventions

Clopidogrel treatment group DRUG

Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.

Clopidogrel treatment group

No antiplatelet or anticoagulant group OTHER

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hanmi Pharmaceutical co., ltd.: collaborator
• Yuhan Pharmaceutical Company: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator
• Dong-A ST Co., Ltd.: collaborator
• IlDong Pharmaceutical Co Ltd: collaborator
• Samjin Pharmaceutical Co., Ltd.: collaborator
• CKD Pharmaceutical Limited: collaborator

Study Sites (61)

Seoul National University Hospital

Seoul, Other, 03080, South Korea

RECRUITING

Andong Hospital

Andong, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Kosin University Gospel Hospital

Busan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

RECRUITING

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

RECRUITING

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Eulji University Hospital, Daejeon

Daejeon, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Kwangju Christian Hospital

Gwangju, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, South Korea

RECRUITING

Eulji University Hospital, Uijeongbu

Gyeonggi-do, South Korea

RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Gyeonggi-do, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Gyeonggi-do, South Korea

RECRUITING

Myongji Hospital

Gyeonggi-do, South Korea

RECRUITING

National Health Insurance Service Ilsan Hospital

Gyeonggi-do, South Korea

RECRUITING

Sejong General Hospital, Bucheon

Gyeonggi-do, South Korea

RECRUITING

Soonchunhyang University Bucheon Hospital

Gyeonggi-do, South Korea

RECRUITING

Yonsei University Yongin Severance Hospital

Gyeonggi-do, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, South Korea

RECRUITING

Catholic Kwandong University International St. Mary's Hospital

Incheon, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

Jeju National University Hospital

Jeju City, South Korea

RECRUITING

Jesus Hospital, Jeonju

Jeonju, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Pohang Stroke And Spine Hospital

Pohang, South Korea

RECRUITING

Chungnam National University Sejong Hospital

Sejong, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, South Korea

RECRUITING

Hallym University Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Hallym University Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Hanyang University Hospital

Seoul, South Korea

RECRUITING

Inje University Sanggye Paik Hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul Medical Center

Seoul, South Korea

RECRUITING

Seoul Metropolitan Government - Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Soonchunhyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Veterans Health Service Medical Center

Seoul, South Korea

RECRUITING

Yonsei University Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Yonsei University Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

Related Publications (14)

• 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.

  PMID: 19944261 BACKGROUND

• 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.

  PMID: 9355934 BACKGROUND

• 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.

  PMID: 16414427 BACKGROUND

• 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.

  PMID: 24573704 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

• 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.

  PMID: 30221597 BACKGROUND

• 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.

  PMID: 30146931 BACKGROUND

• 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.

  PMID: 30158069 BACKGROUND

• 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.

  PMID: 30879355 BACKGROUND

• 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.

  PMID: 34458905 BACKGROUND

• 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.

  PMID: 24090745 BACKGROUND

• 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.

  PMID: 34010616 BACKGROUND

• 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.

  PMID: 21565735 BACKGROUND

• 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.

  PMID: 21757164 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hyo-Soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Jung-Kyu Han, MD, PhD

CONTACT

821026765736; hpcrates@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: March 22, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (61)