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New treatment option for ACS - Acute Coronary Syndrome
Official title CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT06283888
What this study is testing
What is CYP2C19 Genotype Guided DAPT?
CYP2C19 Genotype Guided DAPT is an investigational medicine, being studied as a potential treatment for acs - acute coronary syndrome.
Also referred to as Guided DAPT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zunyi, Guizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zunyi, Guizhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.