NCT05631769

HOST - DAPT Duration According the Bleeding Risk

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,900 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Acute Myocardial Infarction
• Stable Angina

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-07-24
• Primary completion: 2024-12-31
• Completion: 2027-12-31
• First posted: 2022-11-30
• Last updated: 2025-07-23

Locations

1 site across 1 country: South Korea