KCT0007897
Not yet recruiting
未知
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 sites124 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Yonsei University Yongin Severance Hospital
- Enrollment
- 124
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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