Compare VKA vs LMWH in Patients With Anticoagulation Criteria and Episode of Gastrointestinal Bleeding. (Hepaco)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Collaborator:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Candid Villanueva, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01727453
First received: October 31, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

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: cvillanueva@santpau.es. 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


Condition Intervention Phase
Acute Gastrointestinal Bleeding
Drug: warfarin
Drug: Bemiparina
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    upper or lower gastrointestinal bleeding in the follow-up period in both groups.


Secondary Outcome Measures:
  • thromboembolic events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Mortality: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    We included all deaths in this period whatever the reason immediately. Shall specify the date of death to calculate the actuarial probability curves. This will be considered as time 0, the entry in the first hospital where the patient go, or the first bleeding sign if the patient were hospitalized.

    where and when they were admitted first symptom of bleeding.


  • Severity of rebleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    TA, FC, low Hb, transfusion requirements).

  • Association with NSAIDs, aspirin or other antiplatelet agents. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • treatment complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    It will collect any adverse events observed during follow-up, either initially or not attributable to treatment. Notification of serious adverse events and unexpected will be modeled and general instructions contained in Royal Decree 223/2004 of 6 February laying down the requirements for conducting clinical drug trials

  • Time of hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Time of hospitalization during follow-up.

  • Number of hospitalizations during follow-up. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bemiparin
Group 1 (low molecular weight heparin: bemiparin), which is the study group: after passing the bleeding episode, will receive low molecular weight heparin (bemiparin) in anticoagulant dose. Check should be made by measurement of anti-factor Xa.
Drug: Bemiparina

Group 2 (VKA oral anticoagulation: warfarin), which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.

Randomization will be performed using sealed opaque envelopes that contain the treatment option that will be obtained through a list of random numbers generated by computer.

Active Comparator: Warfarin
which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.
Drug: warfarin
Warfarin in anticoagulant dose
Other Name: VKA oral anticoagulationin

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:patients with anticoagulant treatment criteria (treated with acenocoumarol or warfarin) and high or very high risk of embolism, who have an acute gastrointestinal bleeding (high or low) endoscopically untreatable, secondary to multiple vascular lesions, diverticular origin or unclarified origin (after VGC and DC) who have no exclusion criteria.

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Exclusion Criteria:Not be included patients with one or more of the following criteria:

A) less than 18 years old. B) pregnancy. C) patient refusal to participate in the study. D) patients in whom the decision has been taken not to provide active treatment for the existence of any clinical situation considered terminal (severe associated diseases evolved).

E) Contraindication LMWH (allergy, heparin induced thrombocytopenia). F) bleeding secondary to esophageal varices and / or gastric. G) associated bleeding peptic injury. H) bleeding secondary to tumors or polyps. i) Presence of portal hypertension with or without cirrhosis. J) bleeding due to Mallory-Weiss syndrome. K) anticoagulation for low risk embolic lesions

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727453

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Candido Villanueva, MD       cvillanueva@santpau.cat   
Principal Investigator: Candido Villanueva, MD         
Sponsors and Collaborators
Candid Villanueva
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Candid Villanueva, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01727453     History of Changes
Other Study ID Numbers: Hepaco
Study First Received: October 31, 2012
Last Updated: November 12, 2012
Health Authority: Spain: Agencia Española del Medicamento

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Anticoagulants
Heparin, Low-Molecular-Weight
Dalteparin
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014