HOST - DAPT Duration According the Bleeding Risk

Coronary Artery Disease Clinical Trial

— HOST-BR  

Official title:

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631769
• Other study ID #: 2002-150-1105
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: Hyo-Soo Kim, MD, PhD
• Phone: +82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

- Dual antiplatelet agent therapy (DAPT) is essential in treating PCI patients. DAPT can minimize thrombotic adverse events that occur not only at the stented lesion, but along the whole coronary tree. However, DAPT has a critical side effect of increasing bleeding complications. Addressing the clinical imperatives of lowering bleeding while preserving ischemic benefit requires therapeutic strategies that decouple thrombotic from hemorrhagic risk. - Recently, the ARC definition of high bleeding risk (HBR) has been published, so as to stress the need of optimal DAPT treatment in HBR patients. Due to the definitely higher bleeding risk in HBR patients, it would be rather more straight forward to titrate the optimal DAPT duration in these patients. In this line, many studies are in progress on HBR patients, with an ultra-short DAPT duration (i.e. Leaders free, Onyx ONE, Master DAPT, Xience 28, Xience 90, Evolve short DAPT trial, etc.). - As a counteract to the definition of HBR, there is a concept of LBR. Due to the relatively vague ischemic/bleeding risk in LBR patients, balancing ischemic and bleeding complications post-PCI is more difficult in LBR patients, which may be a more important dilemma for clinicians. In this regards, limited evidence exists on the optimal duration of DAPT in LBR patients. Various previous studies that have evaluated the optimal DAPT in PCI populations, did not have the concept of HBR or LBR, making interpretation difficult. - Therefore, this study is planning to compare the efficacy and safety of different DAPT durations, in patients stratified according to the ARB-HBR definition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4900
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• Inclusion Criteria:

1. The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

2. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated.

3. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention.

• Exclusion Criteria:

1. Hypersensitivity to aspirin or P2Y12 inhibitors

2. Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent.

3. Positive pregnancy test or is known to be pregnant

4. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Any life-threatening condition with life expectancy less than 6months, etc.)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Hemorrhage
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stable Angina

Intervention

Drug:
• Dual antiplatelet agent duration
Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Costa F, Van Klaveren D, Feres F, James S, Raber L, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Dual Antiplatelet Therapy Duration Based on Ischemic and Bleeding Risks After Coronary Stenting. J Am Coll Cardiol. 2019 Feb 26;73(7):741-754. doi: 10.1016/j.jacc.2018.11.048. — View Citation

Kang J, Park KW, Palmerini T, Stone GW, Lee MS, Colombo A, Chieffo A, Feres F, Abizaid A, Bhatt DL, Valgimigli M, Hong MK, Jang Y, Gilard M, Morice MC, Park DW, Park SJ, Jeong YH, Park J, Koo BK, Kim HS. Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. Thromb Haemost. 2019 Jan;119(1):149-162. doi: 10.1055/s-0038-1676545. Epub 2018 Dec 31. — View Citation

Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available. Erratum In: Circulation. 2016 Sep 6;134(10):e192-4. — View Citation

Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available. — View Citation

Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240-261. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22. — View Citation

Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Oriented Composite Event	POCE; the composite of Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, Revascularization, or ISTH Bleeding event	1-year after percutaneous coronary intervention
Secondary	Major-Adverse Cardiovascular Event	MACE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, or Revascularization	1-year after percutaneous coronary intervention
Secondary	Any bleeding event	Bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification	1-year after percutaneous coronary intervention
Secondary	Medication compliance	Medication compliance to the allocated DAPT regimen: A 'Pill count adherence' will be used to calculate medication compliance. This will be calculated by the following formula: '[(quantity dispensed)-(quantity remaining)] over (Prescribed number of tablets between dates of interview)'.	1-year after percutaneous coronary intervention
Secondary	Coronary thrombotic event	Myocardial Infarction, Stent thrombosis	1-year after percutaneous coronary intervention
Secondary	All-cause death	Death due to any cause	1-year after percutaneous coronary intervention
Secondary	Cardiac death	Death due to cardiac cause	1-year after percutaneous coronary intervention
Secondary	Non-cardiac death	Death due to non-cardiac cause	1-year after percutaneous coronary intervention
Secondary	Cardiovascular death	Death due to cardiovascular cause	1-year after percutaneous coronary intervention
Secondary	Non-cardiovascular death	Death due to non-cardiovascular cause	1-year after percutaneous coronary intervention
Secondary	Any myocardial infarction	Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis)	1-year after percutaneous coronary intervention
Secondary	Target vessel related myocardial infarction	Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Secondary	Non-Target vessel related myocardial infarction	Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Secondary	Any revascularization	Any coronary revascularization event	1-year after percutaneous coronary intervention
Secondary	Non-Target vessel revascularization	Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Secondary	Target vessel revascularization	Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Secondary	Any stroke	Any cerebrovascular event	1-year after percutaneous coronary intervention
Secondary	Any ischemic stroke	Any ischemic cerebrovascular event	1-year after percutaneous coronary intervention
Secondary	Any hemorrhagic stroke	Any hemorrhagic cerebrovascular event	1-year after percutaneous coronary intervention
Secondary	Major bleeding	Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification	1-year after percutaneous coronary intervention