A clinical trial to evaluate to GastroIntestinal protective eFfect of Tegoprazan for utilization of potent P2Y12 inhibitors in patients with Acute Coronary Syndrome (GIFT-ACS trial)

Yonsei University Yongin Severance Hospital0 个研究点目标入组 124 人开始时间: 待定最近更新: 2022年11月28日

适应症

试验速览

暂无简介。

•Voluntarily consent to the study among patients diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention (PCI)
•- Take dual antiplatelet drugs including potent P2Y12 inhibitor (prasugrel, ticagrelor) for at least 8 weeks after PCI
•- Risk factors for gastrointestinal bleeding (history of gastrointestinal bleeding or ulcer, H.pylori infection (IgG positive), age over 65, taking NSAID or steroid within a month, CKD of eGFR < 60, Hb <13, thrombocoytopenia (PLT <100,000), patients with previous ischemic stroke)

•- A history of hypersensitivity to Potassium-competitive acid blocker (P-CAB) or PPI-based ingredient or benzimidazoles, heparin, aspirin, clopidogrel, prasugrel, or ticagrelor.
•- The use of clopidogrel is required due to the tendency of severe bleeding when taking antiplatelet drug.
•- Cardiac ejection fraction less than 30% in echocardiography
•- Life expectancy less than 12 months based on Visit 1 (first day of screening)
•- The use of ticagrelor or prasugrel is inappropriate because you are taking or need to take an anticoagulant (warfarin, new oral anticoagulant)
•- The risk of bleeding is too high, so the use of antiplatelet drugs is a contraindicated factor
•1) Bleeding stroke, head trauma, brain surgery within 6 months
•2) intracranial tumor
•3) If aortic dissection is suspected
•4) Internal organ bleeding within 6 weeks
•5) In case of active bleeding or bleeding disorder
•6) In case of major surgery, trauma or bleeding within 3 weeks

发起方

Yonsei University Yongin Severance Hospital