The goal of this clinical trial is to learn if zastaprazan can help prevent upper gastrointestinal bleeding in adults who have recently had a transient ischemic attack (TIA) or ischemic stroke and are taking antiplatelet or anticoagulant medications. The main question it aims to answer is:
- Does zastaprazan reduce the risk of upper gastrointestinal bleeding compared to placebo in these patients?
Researchers will compare zastaprazan to a placebo (a look-alike tablet that contains no drug) to see if zastaprazan works to prevent upper gastrointestinal bleeding.
Participants will:
Inclusion Criteria:
Adults aged 19 years or older
Onset of transient ischemic attack (TIA) or ischemic stroke within 180 days prior to randomization
Currently initiating or receiving, at the time of randomization, one of the following treatments, with an expected treatment duration of at least 3 weeks:
A. Dual antiplatelet therapy (DAPT) - aspirin in combination with one of the following: clopidogrel, ticagrelor, prasugrel, or cilostazol B. Oral anticoagulant therapy - a NOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) or warfarin
Provision of written informed consent by the participant (or legally authorized representative)
Exclusion Criteria:
bj.kim@amc.seoul.kr+82-2- 3010-3981
Participants will receive zastaprazan citrate 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).
Participants will receive a matching placebo for zastaprazan 20 mg, administered orally once daily (QD) at a fixed dose, in addition to their prescribed antiplatelet therapy (dual antiplatelet therapy) or oral anticoagulant therapy (NOAC or warfarin).
Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)
Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention
Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)
Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage
Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain
Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage