Compare VKA vs LMWH in Patients With Anticoagulation Criteria and Episode of Gastrointestinal Bleeding.
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
SUMMARY
1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.
1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant
Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.
1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with
antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with
anticoagulation criteria and who have had an episode of gastrointestinal bleeding.
1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr.
Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr.
Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive
Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant
Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax: (34)
93 291 92 78.
E-mail: [email protected]. 1.5. Centers that are planned for the trial: Service
Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.
1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor:
Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret,
167. 08025 Barcelona. Tel: (34) 93 291 9140.
1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main
objective: To compare the incidence of gastrointestinal rebleeding and safety of oral
anticoagulation versus low molecular weight heparin in patients who have had an acute
gastrointestinal bleeding and have indication for anticoagulation.
1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study
disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence
of gastrointestinal bleeding.
1.14. Study population and total number of patients: 20 patients were required in each group
(40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and
10% beta.
1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 -
July 2013
Phase:
Phase 4
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau