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NOT YET RECRUITING
NCT06763744
PHASE4

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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).

Official title: SMart Angioplasty Research Team- Genotype-Guided Abbreviated DUal AntIplatelet Therapy Versus Un-Guided De-escalation Therapy in Patients With Acute Coronary SyndromE and High Bleeding Risk (SMART-GUIDE-HBR)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2025-06-01

Completion Date

2029-12-31

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DRUG

P2Y12 antagonist monotherapy

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.

DRUG

clopidogrel + aspirin

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).

Locations (1)

Samsung Medical Center

Seoul, South Korea