on-randomized confirmatory study of dabigatran bridge therapy in perioperative period of ESD for gastric neoplasms in patients on anticoagulant
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000035353
- Lead Sponsor
- Cancer Institute Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Not provided
1 Patients with non-valvular Af in CHADS2 score of 5 or 6 2 Have allergy for dabigatran 3 Have a plan to perform endoscopic resection for esophageal or duodenal lesion simultaneously 4 Had endoscopic treatment within 28 days from registration 5 Have infection requiring systemic treatments 6 Being or possible pregnant 7 Having psychiatric disorder and judged unsuitable for the clinical study. 8 Continuous systemic use of steroid 9 Using itraconazole which is contraindications of combination with dabigatran 10 Unstable angina (newly occurring or a worsening over the 3 weeks prior to ESD) or myocardial infarction within 6 months prior to ESD 11 Severe respiratory disease requiring continuous oxygen supply 12 Uncontrollable hypertension 13 Uncontrollable diabetes mellitus 14 Patients judged unsuitable for clinical study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method