Comparing Tegoprazan 50 mg Once Daily to Rabeprazole 20 mg Once Daily for Preventing Upper Gastrointestinal Problems in Patients with Heart and Vascular Conditions on Antithrombotic Therapy

What this Trial Is About

Researchers are studying the effectiveness and safety of a new type of drug called a potassium-competitive acid blocker P-CAB, specifically tegoprazan 50 mg taken once daily, compared to a standard proton pump inhibitor PPI, rabeprazole 20 mg once daily. This study focuses on patients with known heart and blood vessel diseases who are at high risk of gastrointestinal GI bleeding because they take long-term antithrombotic medications. The main goal is to see if the P-CAB is at least as good as the PPI in preventing GI problems over a 12-month period after starting treatment. The trial includes two groups one receives tegoprazan 50 mg plus a placebo for rabeprazole, and the other receives rabeprazole 20 mg plus a placebo for tegoprazan. Before randomization, there is a safety surveillance phase with 300 patients taking tegoprazan alone for 6 months to monitor potential side effects like liver problems, high gastrin levels, or infections. If no safety concerns arise, 3,100 patients will be randomly assigned to one of the two study groups and treated for 12 months while being closely monitored. Participants will be involved in regular assessments during the treatment period, where researchers will track the time until the first GI event occurs, including bleeding or ulcers confirmed by tests like endoscopy or CT scans. Other outcomes include rates of various GI complications, cardiovascular safety events, and any side effects related to the drugs. The study carefully monitors safety and effectiveness over one year to provide important data about these treatments for patients at high GI bleeding risk.

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy