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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Clopidogrel treatment group; Other: No antiplatelet or anticoagulant group

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.

• Study Type: Interventional
• Enrollment (Estimated): 11086
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jung-Kyu Han, MD, PhD; Phone Number: 821026765736; Email: hpcrates@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clopidogrel treatment group; Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.	Drug: Clopidogrel treatment group; Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Dong-A ST Co., Ltd.; Daewoong Pharmaceutical Co. LTD.; IlDong Pharmaceutical Co Ltd; Hanmi Pharmaceutical co., ltd.; Yuhan Pharmaceutical Company; Samjin Pharmaceutical Co., Ltd.; CKD Pharmaceutical Limited
• Investigators: Study Chair: Hyo-Soo Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: coronary artery disease; prevention; clopidogrel
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Anticoagulants
• Other Study ID Numbers: H-2212-044-1385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No