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)

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0007897

Lead Sponsor: Yonsei University Yongin Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 124

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
5) In case of active bleeding or bleeding disorder
6) In case of major surgery, trauma or bleeding within 3 weeks

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After 8 weeks of administration of investigational product, the ratio of Modified Lanza score grade 0 to 5 in upper gastrointestinal endoscopy

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptom score (NDI-K);Modified Lanza score 4 to 5 ratio;Gastrointestinal bleeding, BARC type 2,3,5;P2Y12 Reaction Unit (PRU);2 Months Major Cardiac Adverse Events