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HOST - DAPT Duration According the Bleeding Risk (HOST-BR)

Primary Purpose

Coronary Artery Disease, Acute Myocardial Infarction, Stable Angina

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dual antiplatelet agent duration
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring percutenous coronary intervention, dual antiplatelet therapy, bleeding risk

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention. Exclusion Criteria: Hypersensitivity to aspirin or P2Y12 inhibitors Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent. Positive pregnancy test or is known to be pregnant 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.)

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

HBR - 1M DAPT

HBR - 3M DAPT

LBR - 12M DAPT

LBR - 3M DAPT

Arm Description

Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.

Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.

Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.

Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.

Outcomes

Primary Outcome Measures

Patient-Oriented Composite Event
POCE; the composite of Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, Revascularization, or ISTH Bleeding event

Secondary Outcome Measures

Major-Adverse Cardiovascular Event
MACE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, or Revascularization
Any bleeding event
Bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification
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)'.
Coronary thrombotic event
Myocardial Infarction, Stent thrombosis
All-cause death
Death due to any cause
Cardiac death
Death due to cardiac cause
Non-cardiac death
Death due to non-cardiac cause
Cardiovascular death
Death due to cardiovascular cause
Non-cardiovascular death
Death due to non-cardiovascular cause
Any myocardial infarction
Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis)
Target vessel related myocardial infarction
Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Non-Target vessel related myocardial infarction
Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Any revascularization
Any coronary revascularization event
Non-Target vessel revascularization
Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Target vessel revascularization
Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Any stroke
Any cerebrovascular event
Any ischemic stroke
Any ischemic cerebrovascular event
Any hemorrhagic stroke
Any hemorrhagic cerebrovascular event
Major bleeding
Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification

Full Information

First Posted
November 13, 2022
Last Updated
November 26, 2022
Sponsor
Seoul National University Hospital
Collaborators
Hanyang University
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1. Study Identification

Unique Protocol Identification Number
NCT05631769
Brief Title
HOST - DAPT Duration According the Bleeding Risk
Acronym
HOST-BR
Official Title
Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hanyang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Myocardial Infarction, Stable Angina
Keywords
percutenous coronary intervention, dual antiplatelet therapy, bleeding risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBR - 1M DAPT
Arm Type
Experimental
Arm Description
Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.
Arm Title
HBR - 3M DAPT
Arm Type
Active Comparator
Arm Description
Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.
Arm Title
LBR - 12M DAPT
Arm Type
Experimental
Arm Description
Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.
Arm Title
LBR - 3M DAPT
Arm Type
Active Comparator
Arm Description
Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.
Intervention Type
Drug
Intervention Name(s)
Dual antiplatelet agent duration
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patient-Oriented Composite Event
Description
POCE; the composite of Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, Revascularization, or ISTH Bleeding event
Time Frame
1-year after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Major-Adverse Cardiovascular Event
Description
MACE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, or Revascularization
Time Frame
1-year after percutaneous coronary intervention
Title
Any bleeding event
Description
Bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification
Time Frame
1-year after percutaneous coronary intervention
Title
Medication compliance
Description
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)'.
Time Frame
1-year after percutaneous coronary intervention
Title
Coronary thrombotic event
Description
Myocardial Infarction, Stent thrombosis
Time Frame
1-year after percutaneous coronary intervention
Title
All-cause death
Description
Death due to any cause
Time Frame
1-year after percutaneous coronary intervention
Title
Cardiac death
Description
Death due to cardiac cause
Time Frame
1-year after percutaneous coronary intervention
Title
Non-cardiac death
Description
Death due to non-cardiac cause
Time Frame
1-year after percutaneous coronary intervention
Title
Cardiovascular death
Description
Death due to cardiovascular cause
Time Frame
1-year after percutaneous coronary intervention
Title
Non-cardiovascular death
Description
Death due to non-cardiovascular cause
Time Frame
1-year after percutaneous coronary intervention
Title
Any myocardial infarction
Description
Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis)
Time Frame
1-year after percutaneous coronary intervention
Title
Target vessel related myocardial infarction
Description
Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Time Frame
1-year after percutaneous coronary intervention
Title
Non-Target vessel related myocardial infarction
Description
Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Time Frame
1-year after percutaneous coronary intervention
Title
Any revascularization
Description
Any coronary revascularization event
Time Frame
1-year after percutaneous coronary intervention
Title
Non-Target vessel revascularization
Description
Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Time Frame
1-year after percutaneous coronary intervention
Title
Target vessel revascularization
Description
Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'
Time Frame
1-year after percutaneous coronary intervention
Title
Any stroke
Description
Any cerebrovascular event
Time Frame
1-year after percutaneous coronary intervention
Title
Any ischemic stroke
Description
Any ischemic cerebrovascular event
Time Frame
1-year after percutaneous coronary intervention
Title
Any hemorrhagic stroke
Description
Any hemorrhagic cerebrovascular event
Time Frame
1-year after percutaneous coronary intervention
Title
Major bleeding
Description
Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification
Time Frame
1-year after percutaneous coronary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention. Exclusion Criteria: Hypersensitivity to aspirin or P2Y12 inhibitors Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent. Positive pregnancy test or is known to be pregnant 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Soo Kim, MD, PhD
Phone
+82-2-2072-2226
Email
hyosoo@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeehoon Kang, MD
Phone
+82-2-2072-1790
Email
medikang@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeehoon Kang, MD
Phone
+82-2072-1790
Email
medikang@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no pre-defined plan to share IPD, however, any relevant inquiry should be emailed to Dr. Hyo-Soo Kim or Dr. Jeehoon Kang.
Citations:
PubMed Identifier
20626619
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.
Results Reference
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PubMed Identifier
31116032
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.
Results Reference
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PubMed Identifier
30597509
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
27026020
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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HOST - DAPT Duration According the Bleeding Risk

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