NCT06283888 CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
| NCT ID | NCT06283888 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zunyi Medical College |
| Condition | ACS - Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,200 participants in total. It began in 2024-04-01 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Clinical Criteria: * 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. * Patients provide written informed consent before enrollment. 2. Angiographic Criteria (meet at least 1 of the following characteristics): * Thrombotic target lesion. * Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy * Multivessel (≥2 vessels) disease will be treated. * Multi-target lesions (≥3 lesions) will be treated. * Multi-stent (≥3 stents) will be implanted. * Total stent length≥60 mm. * Bifurcation lesion requiring at least 2 stents. * PCI for left main. * PCI for chronic total occlusion. * PCI for bypass graft. Exclusion Criteria: * 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) * Intracranial/gastrointestinal/urogenital bleeding within 6 months. * Active bleeding or bleeding diathesis, thrombocytopenia (platelet \<100,000/mL) or hemoglobin \<10 g/dL * Hepatic dysfunction (serum liver enzyme\>3 times the normal limit) * Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis) * Concomitant therapy with a strong CYP3A4 inhibitor or inducer * Life expectancy \< 1 year
Contact & Investigator
Cai De Jin
PRINCIPAL INVESTIGATOR
Zunyi Medical College
Frequently Asked Questions
Who can join the NCT06283888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ACS - Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06283888 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06283888 currently recruiting?
Yes, NCT06283888 is actively recruiting participants. Contact the research team at jincaide1118@163.com for enrollment information.
Where is the NCT06283888 trial being conducted?
This trial is being conducted at Zunyi, China.
Who is sponsoring the NCT06283888 clinical trial?
NCT06283888 is sponsored by Zunyi Medical College. The principal investigator is Cai De Jin at Zunyi Medical College. The trial plans to enroll 1,200 participants.