Active — Not RecruitingPhase 4

HOST - DAPT Duration According the Bleeding Risk

South Korea4,900 participantsStarted 2020-07-24

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Net Adverse Clinical Events

Timeframe: 1-year after percutaneous coronary intervention

Any bleeding event

Timeframe: 1-year after percutaneous coronary intervention

Major-Adverse Cardiac or Cerebral Events

Timeframe: 1-year after percutaneous coronary intervention

Trial details

NCT IDNCT05631769

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.