Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR

NCT06763744 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GUIDE-HBR
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).

Conditions

Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI); High Bleeding Risk

Keywords

CYP2C19 Genotype; Acute coronary syndrome; De-escalation therapy; P2Y12 inhibitor monotherapy; High bleeding risk

Outcome Measures

Primary Outcomes (1)

• Major or clinically relevant non-major bleeding

  Bleeding Academic Research Consortium type 2, 3, or 5

  6 months after PCI

Secondary Outcomes (30)

• Major bleeding

  6 months after PCI

• Clinically relevant non-major bleeding

  6 months after PCI

• Net adverse clinical event

  6 months after PCI

• Major adverse cardiac and cerebrovascular event

  6 months after PCI

• All-cause death

  6 months after PCI

Study Arms (2)

Genotype-guided abbreviated DAPT

ACTIVE COMPARATOR

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 inhibitor (prasugrel or ticagrelor) monotherapy (patients carrying a CYP2C19\*2 or \*3 alleles) after 1 month of potent P2Y12 inhibitor based DAPT.

Drug: P2Y12 antagonist monotherapy

Un-guided de-escalation of DAPT

ACTIVE COMPARATOR

A potent P2Y12 inhibitor is changed to clopidogrel 1 month after PCI, and aspirin is maintained.

Drug: clopidogrel + aspirin

Interventions

P2Y12 antagonist monotherapy DRUG

CYP2C19 genetic testing is performed before discharge after stent insertion. Depending on the test results, rapid (CYP2C19\*1/\*17 or \*17/\*17) or normal (CYP2C19\*1/\*1) metabolizers are treated with clopidogrel monotherapy, and intermediate or poor metabolizers (with CYP2C19\*2 or \*3 alleles) are treated with potent P2Y12 inhibitors (prasugrel or ticagrelor) monotherapy.

Genotype-guided abbreviated DAPT

clopidogrel + aspirin DRUG

In this group, a potent P2Y12 inhibitor was changed to clopidogrel (un-guided) 1 month after PCI with maintenance of co-prescription of aspirin (DAPT).

Un-guided de-escalation of DAPT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo-Yong Hahn, MD, PhD

CONTACT

82-2-3410-3419; jyhahn@skku.edu

Ki Hong Choi, MD, PhD

CONTACT

82-2-3410-6653; cardiokh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open-label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

KR (1)