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| Name | Class |
|---|---|
| Samjin Pharmaceutical Co., Ltd. | INDUSTRY |
| CKD Pharmaceutical Limited | UNKNOWN |
| Hanmi Pharmaceutical co., ltd. | OTHER |
| Yuhan Pharmaceutical Company |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel treatment group | Experimental | Patients 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel treatment group | Drug | Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 5 years after the last enrollment |
| Net adverse clinical event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Kyu Han, MD, PhD | Contact | 821026765736 | hpcrates@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Other | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19944261 | Background | 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. | |
| 9355934 | 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. |
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| UNKNOWN |
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
| Dong-A ST Co., Ltd. | INDUSTRY |
| IlDong Pharmaceutical Co Ltd | INDUSTRY |
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| 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. |
|
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke or transient ischemic attack, major bleeding |
| 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 |
| Ischemic stroke or Transient ischemic attack | at 2 years and 5 years after the last enrollment |
| Any non-coronary revascularization | at 2 years and 5 years after the last enrollment |
| Major bleeding events | BARC classification, type 3 or 5 | at 2 years and 5 years after the last enrollment |
| BARC type 2 bleeding events | at 2 years and 5 years after the last enrollment |
| BARC type 3 bleeding events | at 2 years and 5 years after the last enrollment |
| BARC type 5 bleeding events | at 2 years and 5 years after the last enrollment |
| Andong Hospital | Recruiting | Andong | South Korea |
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| Dong-A University Hospital | Recruiting | Busan | South Korea |
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| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
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| Pusan National University Hospital | Recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Soonchunhyang University Cheonan Hospital | Recruiting | Cheonan | South Korea |
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| Soonchunhyang University Cheonan Hospital | Recruiting | Cheonan | South Korea |
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| Soonchunhyang University Cheonan Hospital | Recruiting | Cheonan | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
|
| Hallym University Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
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| Yeungnam University Medical Center | Recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
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| Eulji University Hospital, Daejeon | Recruiting | Daejeon | South Korea |
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| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
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| Kwangju Christian Hospital | Recruiting | Gwangju | South Korea |
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| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Eulji University Hospital, Uijeongbu | Recruiting | Gyeonggi-do | South Korea |
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| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Hallym University Sacred Heart Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Inje University Ilsan Paik Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Myongji Hospital | Recruiting | Gyeonggi-do | South Korea |
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| National Health Insurance Service Ilsan Hospital | Recruiting | Gyeonggi-do | South Korea |
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| Sejong General Hospital, Bucheon | Recruiting | Gyeonggi-do | South Korea |
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| Soonchunhyang University Bucheon Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Yonsei University Yongin Severance Hospital | Recruiting | Gyeonggi-do | South Korea |
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| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | South Korea |
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| Catholic Kwandong University International St. Mary's Hospital | Recruiting | Incheon | South Korea |
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| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
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| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
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| Jesus Hospital, Jeonju | Recruiting | Jeonju | South Korea |
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| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
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| Pohang Stroke And Spine Hospital | Recruiting | Pohang | South Korea |
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| Chungnam National University Sejong Hospital | Recruiting | Sejong | South Korea |
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| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Hallym University Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| Hallym University Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | South Korea |
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| Hanyang University Hospital | Recruiting | Seoul | South Korea |
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| Inje University Sanggye Paik Hospital | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul Medical Center | Recruiting | Seoul | South Korea |
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| Seoul Metropolitan Government - Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
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| Soonchunhyang University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Veterans Health Service Medical Center | Recruiting | Seoul | South Korea |
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| Yonsei University Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| Yonsei University Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
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| 16414427 | 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. |
| 24573704 | 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. |
| 30165437 | 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. |
| 30221597 | 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. |
| 30146931 | 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. |
| 30158069 | 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. |
| 30879355 | 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. |
| 34458905 | 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. |
| 24090745 | 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. |
| 34010616 | 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. |
| 21565735 | 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. |
| 21757164 | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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