[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cyp2c19-polymorphism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cyp2c19-polymorphism":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100538536","implementation-of-onsite-rapid-cyp2c19-assay-for-genotype-guided-dual-antiplatelet-therapy-after-acute-ischemic-stroke-100538536",false,"NCT06292117","Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke","ORCA-AIS","Inclusion Criteria:\n\n* Men and women at least 18 years of age\n* Presenting with symptoms of acute ischemic stroke or transient ischemic attack and without contraindications to dual antiplatelet therapy at time of clinical research coordinator screening\n* Presenting within 24 of symptom onset; or, within 24-96 hours of symptom onset IF planned to receive or already on dual antiplatelet therapy\n\nExclusion Criteria:\n\n* Receiving therapeutic anticoagulation or clear indication for initiation of anticoagulation after event (e.g., known atrial fibrillation)\n* History of allogeneic bone marrow transplant\n* History of liver transplant\n* Subject who is unable to consent and does not have a surrogate available to consent on their behalf","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.\n\nThe main questions this study aims to answer are:\n\n* What are the best strategies to implement this genetic test in the hospital?\n* Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?\n\nParticipants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.",[24,25],"Ischemic Stroke","CYP2C19 Polymorphism",[27,28,29,30],"pharmacogenomics","pharmacogenetics","dual antiplatelet therapy","secondary prevention of ischemic stroke","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-06","ACTUAL",{"date":37,"type":35},"2024-04-16",{"date":39,"type":20},"2026-10",{"name":41,"class":42},"University of Virginia","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100510425","phase-2-popular-guilty-pilot-genotype-guided-clopidogrel-monotherapy-100510425","NCT05926271","POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy","POPular GUILTY","Inclusion Criteria:\n\nPatients aged 18 years or older are eligible for inclusion if all of the following criteria are met:\n\n* Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)\n* Successful PCI (according to the treating physician) with implantation of new generation drug eluting stents.\n* CYP2C19 extensive or ultra-rapid metabolizer\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* CYP2C19 poor or intermediate metabolizer\n* Known allergy or contraindication for aspirin or clopidogrel.\n* Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)\n* Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)\n* High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length \\>60 mm\n* Recent stroke, transient ischemic attack (TIA) or intracranial bleeding\n* Severe hepatic impairment (Child Pugh class C)\n* Planned surgical intervention within 6 months of PCI\n* Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)\n* Pregnant or breastfeeding women at time of enrolment\n* Participation in another trial with an investigational drug or device",true,{"count":53,"type":20},200,"INTERVENTIONAL",[56],"PHASE2","The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). The main questions it aims to answer are:\n\n* Is genotype-guided clopidogrel monotherapy effective in reducing ischemic risk during the first six months following successful PCI?\n* Is genotype-guided clopidogrel monotherapy safe in terms of reducing bleeding risk during the first six months following successful PCI?\n\nParticipants will be given genotype-guided clopidogrel monotherapy after their successful PCI procedure and will be monitored for any bleeding or ischemic complications over the next six months.\n\nResearchers will compare these results to the typical outcomes associated with traditional Dual antiplatelet therapy (DAPT) to see if genotype-guided clopidogrel monotherapy provides similar or improved protection from ischemic events, but with fewer bleeding complications.",[59,25],"Acute Coronary Syndrome",[61,62,63,64],"Acute coronary syndrome","Monotherapy","P2Y12 inhibitor","Aspirin free strategy","2024-11-28",{"date":67,"type":35},"2024-12-03",{"date":69,"type":35},"2023-07-15",{"date":71,"type":20},"2027-01-15",{"name":73,"class":42},"St. Antonius Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":43},"100537904","phase-4-cyp2c19-genotype-guided-p2y12-receptor-inhibitor-selection-after-complex-percutaneous-coronary-intervention-100537904","NCT06283888","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","Inclusion Criteria:\n\n1. Clinical Criteria:\n\n   * Patients aged between 18-80 years old.\n   * Patients with ACS (UA\u002FNSTEMI\u002FSTEMI) undergoing PCI.\n   * Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months.\n   * Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping.\n   * Patients provide written informed consent before enrollment.\n2. Angiographic Criteria (meet at least 1 of the following characteristics):\n\n   * Thrombotic target lesion.\n   * Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy\n   * Multivessel (≥2 vessels) disease will be treated.\n   * Multi-target lesions (≥3 lesions) will be treated.\n   * Multi-stent (≥3 stents) will be implanted.\n   * Total stent length≥60 mm.\n   * Bifurcation lesion requiring at least 2 stents.\n   * PCI for left main.\n   * PCI for chronic total occlusion.\n   * PCI for bypass graft.\n\nExclusion Criteria:\n\n* Patient with known CYP2C19 genotype before randomization.\n* Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.\n* Planned surgery within 90 days.\n* Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)\n* Intracranial\u002Fgastrointestinal\u002Furogenital bleeding within 6 months.\n* Active bleeding or bleeding diathesis, thrombocytopenia (platelet \\\u003C100,000\u002FmL) or hemoglobin \\\u003C10 g\u002FdL\n* Hepatic dysfunction (serum liver enzyme\\>3 times the normal limit)\n* Renal failure (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2 or requiring dialysis)\n* Concomitant therapy with a strong CYP3A4 inhibitor or inducer\n* Life expectancy \\\u003C 1 year","80 Years",{"count":83,"type":20},1200,[85],"PHASE4","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.",[88,25],"ACS - Acute Coronary Syndrome",[90,91,92],"CYP2C19 Genotype","P2Y12 Receptor Inhibitor","Complex PCI","2024-03-18",{"date":95,"type":35},"2024-03-20",{"date":97,"type":20},"2024-04-01",{"date":99,"type":20},"2028-12-01",{"name":101,"class":42},"Zunyi Medical College"]