Comparative efficacy and safety of proton pump inhibitor co-therapy with direct oral anticoagulants

Gastrointestinal protection Using proton-pump inhibitor in pAtients who RequireD Oral AntiCoagulatns - randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006848

Enrollment

3846

Registered

2021-12-21

Start date

2022-01-24

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients of cardiovascular disease who are expected to take direct oral anticoagulants (DOAC) for longer than one year will be randomized to either [concomitant use of the proton pump inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Clinical events of upper gastrointestinal tract	—

Secondary

Measure	Time frame
Other clinical events of upper gastrointestinal tract, composite of cardiovascular event outcomes, all-cause mortality, side effects of PPI	—

Countries

Korea, Republic of

Contacts

Public ContactSo-Ryoung Lee

Seoul National University Hospital

minerva1368@gmail.com+82-2-2072-1472

Outcome results