Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR (NCT06763744) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR
South Korea3,000 participantsStarted 2025-06-01
Plain-language 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).
Who can participate
Age range19 Years
SexALL
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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:
* 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.