Comparative efficacy and safety of proton pump inhibitor co-therapy with direct oral anticoagulants
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006848
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3846
1. Cardiovascular disease patients who are required to take direct oral anticoagulants (DOAC) for longer than one year
2. HAS-BLED score = 1
3. Age = 19 years old with informed consent
1. History of taking PPI, P-CAB, H2 receptor blocker, sucralfate, misoprostol within 2 weeks of study enrollment or requiring continuous medications
2. Patients with evidence of active bleeding or coagulopathy,
3. Patients who underwent major procedure or operation that can affect secretion of gastric acid.
4. Zollinger-Ellison syndrome patients or patients with disturbances in gastric acid secretion
5. Contraindication to anticoagulation
6. Hemodynamic instability at the enrollment
7. Severe anemia and history of transfusion within 4 weeks of study enrollment
8. Severe thrombocytopenia
9. Chronic kidney disease (on dialysis or creatinine clearance <15ml/min)
10. Severe chronic liver disease
11. Hypersensitivity or contraindication to PPI
12. Current use of dual antiplatelet agents
13. Current use of CYP3A4 p-glycoprotein inhibitor
14. Current use of Atazanavir, nelfinavir, or rilpivirine
15. Other clinical significant contraindications to study enrollment
16. Known or suspicious malignant disease.
17. Life expectancy less than a year
18. Women with childbearing age
19. Expected to get an operation requiring admission
20. Participating in other randomized clinical trials within 12 months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical events of upper gastrointestinal tract
- Secondary Outcome Measures
Name Time Method Other clinical events of upper gastrointestinal tract, composite of cardiovascular event outcomes, all-cause mortality, side effects of PPI
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.