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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Genotype-guided abbreviated DAPTActive comparator 1 intervention
Group B: Un-guided de-escalation of DAPTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major or clinically relevant non-major bleeding

Bleeding Academic Research Consortium type 2, 3, or 5

Time frame
6 months after PCI

Secondary outcomes

1

Major bleeding

BARC type 3 or 5

Time frame
6 months after PCI
2

Clinically relevant non-major bleeding

BARC type 2

Time frame
6 months after PCI
3

Net adverse clinical event

A composite of all-cause death, MI, stroke, stent thrombosis, and major bleeding

Time frame
6 months after PCI
4

Major adverse cardiac and cerebrovascular event

A composite of all-cause death, MI, stent thrombosis, or stroke

Time frame
6 months after PCI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: