NCT01727453: HEPACO

Randomized Controlled Trial to Compare Treatment With Oral Anticoagulation With Antagonists of vitaminK vs Low Molecular Weight Heparin(Bemiparin) in Patients With Anticoagulation Criteria and an Episode of Gastrointestinal Bleeding.

Completed Phase 4 Last updated 17 September 2015

What this trial tests

Phase 4 trial testing warfarin in Acute Gastrointestinal Bleeding in 40 participants. Completed in 1 September 2015.

Timeline

1 December 2011

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 December 2011
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	1 location across Spain

Drugs / interventions tested

• warfarin (warfarin) — full drug profile →
• Bemiparina — full drug profile →

Conditions studied

• Acute Gastrointestinal Bleeding — all drugs for Acute Gastrointestinal Bleeding →

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Who can join

18 and older, any sex, with Acute Gastrointestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Rebleeding
  Time frame: 1 year
  upper or lower gastrointestinal bleeding in the follow-up period in both groups.

Sponsor's own description

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: [phone] 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: [phone]. Fax: [phone].

E-mail: [e-mail]. 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: [phone].

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.