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A Pilot Study on Gastrointestinal Protection and Safety of Zastafrazan in Patients with Antithrombotic agents

A randomized, double-blind, placebo controlled, multicenter, parallel group pilot study on the gastrointestinal protective effect and safety of zastaprazan citrate in patients taking antithrombotic agent

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011993
Enrollment
250
Registered
2026-05-15
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-18

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. JaQbo group: JaQbo Tab., 20 mg, once a day, 6 months, Per Os 2. A placebo that looks exactly 'JaQbo Tab. 20 mg' shape and has no medicinal effect, once a day, 6 months, Per Os

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults over the age of 19 2) Patients who have agreed to study gastrointestinal protection while receiving antiplatelet (aspirin or P2Y12 receptor blocker) or anticoagulant (warfarin or NOAC) treatment (1) a patient on Antiplatelet drugs have already been used to prevent and treat blood clots in patients with cardiovascular disease, cerebrovascular disease, and peripheral arterial disease (2) To prevent retraction after coronary stent procedure due to acute myocardial infarction, antiplatelet drugs have already been taken a patient, (3) Patients who are already taking anticoagulants to prevent stroke in patients with atrial fibrillation, (4) Patients who are already taking anticoagulants to treat deep vein thrombosis and pulmonary embolism, or (5) Patients who have undergone heart valve procedures (or surgery) and are already taking anticoagulants for the prevention of blood clots

Exclusion criteria

Exclusion criteria: 1) A person who is deemed difficult to continue antithrombotic treatment by a clinician due to repeated bleeding history (intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hematopoiesis, etc.) or risk of bleeding 2) Sensitive to antiplatelet drugs, anticoagulants, or JaQbo 3) When antiplatelet drugs and anticoagulants are used in combination 4) Study registration If patients have taken a gastric acid secretion inhibitor (PPI or P-CAB) at least once within 4 weeks 5) Using atazanavir, nelfinavir, or Ripivirine containing medications 6) Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 7) Liver disease 8 Renal failure 9) If suspected malignancy (significant unintended weight loss, recurrent vomiting, difficulty swallowing, hemoptysis, melena, etc.) and have a gastric ulcer 10) Taking nonsteroidal anti-inflammatory drugs (NSAIDs; aceclofenac, meloxicam, naproxen) 11) Taking CYP3A4/CYP3A5 inducer and inhibitor 12) Taking clarithromycin and amoxicillin together 13) Pregnant or Breastfeeding 14) Women of childbearing age who have a pregnancy plan during the study period 15) A person whose life expectancy is less than 6 months 16) Other persons deemed unfit by the tester to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
The number of upper gastrointestinal bleeding events

Secondary

MeasureTime frame
Upper gastrointestinal symptoms such as heartburn, epigastric pain, nausea or vomiting, frequent belching or abdominal bloating, bitterness or coming over, or upper gastrointestinal symptoms, etc.

Countries

Korea, Republic of

Contacts

Public ContactSung-Ji Park

Samsung Medical Center

tyche.park@gmail.com+82-2-3410-2754

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: May 22, 2026