NCT06283888RecruitingPhase 4
CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
Safety and Efficacy of CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection Versus Conventional Antiplatelet Therapy After Complex Percutaneous Coronary Intervention: The PRECISE-PCI Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 20 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Zunyi Medical College
- Diseases
- Coronary artery disease
- NCT number
- NCT06283888
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1200
- From 1 Apr 2024 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery within 90 days.
- Concomitant therapy with a strong CYP3A4 inhibitor or inducer
Other illness
- Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)
- Intracranial/gastrointestinal/urogenital bleeding within 6 months.
Lab values
- 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)
Other
- Patient with known CYP2C19 genotype before randomization.
- Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.
- Life expectancy \< 1 year
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.