CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study)

GUARANTEE

The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor in carriers of a CYP2C19\*2 or \*3 allele in patients treated with new generation drug eluting stents.

2019-05-27

2024-12-01

2025-02-01

Recruiting

4009

Inclusion Criteria: * Patient ≥18 years of age * Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD) * Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted Exclusion Criteria: * Patient unable to receive 12 months of dual anti-platelet therapy * Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI * Contraindicated or allergic to clopidogrel or ticagrelor * Patient or physician refusal to enroll in the study * Patient having received thrombolytic therapy within the previous 24 hours * Physician has known the patient's CYP2C19 genotype * Anticipated discontinuation of dual anti-platelet therapy within the 12-month follow-up period, example for elective surgery * History of intracranial hemorrhage * Patient has a history of bleeding diathesis or coagulopathy * Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding * Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months * Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor) * Patient with cardiogenic shock or mechanical circulatory assist devices placed * Patient with LVEF \<30% * Patient with active liver diseases * Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation) * Patient has a malignancy or a life expectancy of less than one year * Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4009, 'type': 'ESTIMATED'}}

2023-09-28