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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007897

Enrollment

110

Registered

2022-11-11

Start date

2022-12-19

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Investigational product - Test drug: K-CAB tablet 50mg(tegoprazan), Rabeone tablet 10mg(rabeprazole sodium) placebo - Control drug: Rabeone tablet 10mg(rabeprazole sodium), K-CAB tablet 50mg

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactCheal Wung Huh

Yonsei University Yongin Severance Hospital

gjcjfdnd01@naver.com+82-31-5189-9702

Outcome results