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

Launched by SAMSUNG MEDICAL CENTER · Jan 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment strategies for patients with acute coronary syndrome (ACS), which is a serious heart condition, who are at high risk for bleeding and are undergoing a procedure called percutaneous coronary intervention (PCI). The trial aims to compare a personalized approach to medication based on a specific gene test (genotype-guided abbreviated dual antiplatelet therapy) with a more general approach (un-guided stepwise intensity de-escalation therapy). The goal is to find out which method is safer and more effective for these patients.

To be eligible for this trial, participants must be at least 19 years old and able to understand the study’s risks and benefits to give their consent. They should be experiencing symptoms of ACS and have a significant blockage in their heart arteries that requires treatment. Additionally, they must have a high risk of bleeding based on specific medical scores. Participants in the trial will receive careful monitoring and support throughout the study. It’s important to know that certain individuals, such as those with specific heart conditions or severe bleeding risks, may not be eligible to participate.

Gender

ALL

Eligibility 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:
• • 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.