Clinical trial · Interventional
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
NCT04214990CI-TRIAL-00084148EASTERNrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to investigate the effect of low-dose (100 mg) asprin on the prevention of gastric cancer in the early gastric cancer patients with negative H. pylori status who underwent endoscopic submucosal dissection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspirin | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin 100mg | Drug | Aspirin | ALIAS |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- Enteric coated aspirin
- interventionNames
- Drug: Aspirin 100mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Enteric coated aspirin placebo
- interventionNames
- Drug: Placebo oral tablet
Primary outcomes (1)
- measure
- The incidence of gastric cancer between the intervention and placebo groups
- timeFrame
- Until last enrolled patients take 5-year trial medication
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged 19-70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer (category 4 \[non-invasive high grade neoplasm\] or category 5 \[invasive neoplasia\] according to the Vienna classification of gastrointestinal epithelial neoplasia \[Schlemper RJ, et al. Gut 2000;47:251-255.\]) * Final pathological results after endoscopic resection met the absolute or expanded criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4) * Patients who had negative H. pylori status or those who eradicated H. pylori status * Willingness to sign an informed consent form Exclusion Criteria: * Patients who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases * Regular aspirin uses (more than 3 times a week) with 2 months before screening visit * Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose * Previous gastrectomy history * Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection) * High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc) * Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled) * Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years * Non-curative resection of early gastric cancer after endoscopic resection * Aspirin allergy or contraindication of aspirin use * Pregnant or lactating women * Alcoholism, drug abuse * Inadequate patients for study enrollment according to the evaluation of the study physician * Inability to provide an informed consent * Patients who took a 28-day run-in-period medication less than 80%
References
Publications (0)
Data not yet available
No reference posted for this study.