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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • P2Y12 antagonist monotherapy
  • clopidogrel + aspirin

Treatment groups

3,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators