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CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention

ConditionsACS - Acute Coronary SyndromeCYP2C19 Polymorphism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZunyi Medical College

About this trial

In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18-80 years old.

Patients with ACS (UA/NSTEMI/STEMI) undergoing PCI.

Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months.

Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping.

Disqualifiers

Patient with known CYP2C19 genotype before randomization.

Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.

Planned surgery within 90 days.

Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CYP2C19 Genotype Guided DAPT

    Drug

    Patients with \*2 or \*3 carrier will be received ticagrelor 60mg or 45mg bid (if \<50 kg, ≥75 years) + aspirin 100 mg qd; Patients with \*2 or \*3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd

  • Conventional DAPT

    Drug

    Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: CYP2C19 Genotype Guided DAPTExperimental treatment 1 intervention
Group B: Conventional DAPTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NACE (net adverse clinical event)

The incidence of NACE (composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or clinically significant bleeding according to BARC criteria).

Time frame
At 12 months

Secondary outcomes

1

Incidence of clinically significant bleeding

The Bleeding Academic Research Consortium (BARC)-defined clinically significant bleeding (type 2, 3, or 5 bleeding) as follows: Type 2: Any overt, actionable sign of hemorrhage, requiring nonsurgical, medical intervention by a healthcare professional; Leading to hospitalization or increased level of care; Prompting evaluation. Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL; Any transfusion with overt bleeding. Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring intravenous vasoactive agents. Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision. Type 5: Fatal bleeding is bleeding that directly causes death with no other explainable cause.

Time frame
At 12 months
2

Incidence of MACCE

The incidence of major adverse cardiac and cerebrovascular event (MACCE), is composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, or stroke.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Zunyi Medical College

Lead sponsor

Source ClinicalTrials.gov
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