Comparison of Outcomes Between Genotype-Guided Abbreviated Dual Antiplatelet Therapy Versus Un-Guided De-escalation Therapy in Patients with Acute Coronary Syndrome and High Bleeding Risk

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010185

Enrollment

3000

Registered

2025-02-10

Start date

2025-03-04

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Rapid (CYP2C19*1/*17 or *17/*17) or normal metabolizers (CYP2C19*1/*1) for clopidogrel will receive clopidogrel monotherapy and intermediate or poor metabolizers will receive potent P2Y12 inhib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must be at least 19 years of age Patients who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. Patients presenting with ACS (ST-elevation myocardial infarction [STEMI] or non-ST-elevation [NSTE] ACS). Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents in native coronary artery or graft. Patients with high bleeding risk (by ARC-HBR definition or PRECISE-DAPT score 25 or more)

Exclusion criteria

Exclusion criteria: Patients unable to provide consent. Patients who need chronic anti-coagulation therapy. Patients suffering from cardiogenic shock or cardiac arrest Patients with known intolerance to aspirin, all P2Y12 inhibitors, or components of drug-eluting stents. Clinically significant out of range values for platelet count (< 50,000/mm3) or hemoglobin (<8 g/dL) at screening Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment). Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Bleeding Academic Research Consortium type 2, 3, or 5	—

Secondary

Measure	Time frame
Major bleeding BARC type 3 or 5;Clinically relevant non-major bleeding BARC type 2;Net adverse clinical event;Major adverse cardiac and cerebrovascular event ;All-cause death Death from any causes;Cardiovascular death;Myocardial Infarction; Stent thrombosis;Stroke; Repeat revascularization;Target vessel revascularization;Target lesion revascularization;cardiovascular death, MI, stent thrombosis, or stroke;cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization;Total medical cost;Major or clinically relevant non-major bleeding;Major bleeding; Clinically relevant non-major bleeding;Net adverse clinical event; Major adverse cardiac and cerebrovascular event; All-cause death;Cardiovascular death; Stent thrombosis;Stroke;Repeat revascularization; Target vessel revascularization;Target lesion revascularization;cardiovascular death, MI, stent thrombosis, or stroke;cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization	—

Measure

Time frame

Major bleeding BARC type 3 or 5;Clinically relevant non-major bleeding BARC type 2;Net adverse clinical event;Major adverse cardiac and cerebrovascular event ;All-cause death Death from any causes;Cardiovascular death;Myocardial Infarction; Stent thrombosis;Stroke; Repeat revascularization;Target vessel revascularization;Target lesion revascularization;cardiovascular death, MI, stent thrombosis, or stroke;cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization;Total medical cost;Major or clinically relevant non-major bleeding;Major bleeding; Clinically relevant non-major bleeding;Net adverse clinical event; Major adverse cardiac and cerebrovascular event; All-cause death;Cardiovascular death; Stent thrombosis;Stroke;Repeat revascularization; Target vessel revascularization;Target lesion revascularization;cardiovascular death, MI, stent thrombosis, or stroke;cardiovascular death, MI, stent thrombosis, stroke, or repeat revascularization

—

Countries

Korea, Republic of

Contacts

Public ContactHYEONJU LEE

Samsung Medical Center

smcq13955@naver.com+82-2-3410-0742

Outcome results