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NCT06665919Befejeződött

The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models

Randomized Controlled Trial for Evaluating CYP2C19 Allele Genotype-guided Clopidogrel Treatment Outcomes in Real-world Practice After the ePCI

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 26.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug metabolism. The study aimed to answer two research questions: * Does CYP2C19 genotype-guided clopidogrel treatment provide better clinical outcomes when compared with conventional treatment selection led without CYP2C19 genotyping? * Can CYP2C19 genotype-guided antiplatelet treatment be beneficially applied in real-world clinical practice? After obtaining the informed consent eligible study participants screened by inclusion and exclusion criteria were randomized and allocated into two groups: * for whom the CYP2C19 genotype-guided clopidogrel treatment has been applied - the experimental group, * for whom conventional clopidogrel has been applied without CYP2C19 genotyping - the control group. The experimental group participants underwent CYP2C19 genotyping. Study participants with CYP2C19 normal function alleles (NFA) *2, *3 genotypes constituted the separate experimental arm and received clopidogrel-based preventive antiplatelet treatment. Participants with CYP2C19 *2 and *3 loss of function (LoF) alleles were allocated to the separate experimental group and received preventive antiplatelet treatment alternative to clopidogrel. Study participants who had not undergone CYP2C19 genotyping and received conventional preventive antiplatelet treatment with clopidogrel were assigned as active comparators. All participants in the experimental and comparator groups underwent standard clinical investigations by current guideline recommendations for: * the initial assessment, * follow-up and detection of major adverse cardiovascular events. All patients received the conventional drug treatment by current guideline recommendations for chronic coronary artery disease and comorbid condition management and adverse cardiovascular events prevention. The main research outcome measures include: * evaluating clinical outcomes of CYP2C19 genotype-guided antiplatelet treatment application, * describing models for application of CYP2C19 genotype-guided antiplatelet treatment, * learning about potential access points to the real practice process pipeline for implementation of genotype-guided medication treatment.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
283 (tényleges)
Első benyújtás
2024. szept. 29.
Kezdés
2023. jún. 15.
Elsődleges befejezés
2025. máj. 15.
Fő szponzor
Vistamedi Ltd.
NCT-szám
NCT06665919

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 283
  • 2023. jún. 15. és az elsődleges befejezés (2025. máj. 15.) között
  • 4 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Concomitant using of potent CYP3A4 or CYP2C19 inhibitors;
  • Current chemotherapy or immunosuppressive therapy;

Más betegség

  • Type 1 diabetes mellitus;
  • Valvular heart disease due to dysplasia, connective tissue disorders or inflammatory disorders, or valvular disorders requiring cardiac surgery;
  • History of severe hepatic impairment;
  • Severe chronic kidney disease;
  • History of hemorrhagic diathesis or coagulopathy;
  • An active or an obvious threat of bleeding (including GI bleeding):
  • Bleeding within the past 6 months that required hospitalization;
  • History of intracranial hemorrhage;
  • Cardiac or non-cardiac degenerative disease, including: cardiomyopathy, restrictive lung disease, or Neurodegenerative diseases;
  • Malignant tumor (cancer) that limits life expectancy to less than one year;
  • Ongoing immunosuppression or immunosuppressive conditions;
  • Any disease/condition control of which is not achieved;

Laborértékek

  • Poorly controlled type 2 diabetes mellitus, HbA1c - 9% or more;

Egyéb

  • Morbid obesity, BMI 40 kg/sq.m or more;
  • Acute Myocardium Infarction;
  • Coronary artery bypass grafting performed within the last 12 weeks;
  • Clinically important leucopenia, lymphopenia, thrombocytopenia or thrombocytosis;
  • Blood transfusion during the past 6 months or its refusal;
  • Pregnancy or lactation period;
  • Personal (patient/physician dependent) or health care system-related circumstances that can restrict or limit any study procedures or operations.

Kiket keres a vizsgálat

  • Diagnosed with chronic coronary artery disease;
  • Undergone elective PCI within the last 12 weeks without procedure-related complications;
  • LVEF≥38% after index PCI;
  • Completed informed consent form for participation in the study;

Életkor a regiszterben: 35 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (4)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Tbilisi Institute of MedicineTbilisiGrúziaIsmeretlen állapot
T. Oragvelidze Cardiology CenterTbilisiGrúziaIsmeretlen állapot
1st University Clinic of the Tbilisi State Medical UniversityTbilisiGrúziaIsmeretlen állapot
Cardio Expert Ltd., Clinic CardioTbilisiGrúziaIsmeretlen állapot

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