Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT00689520
First received: May 28, 2008
Last updated: June 2, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.


Condition Intervention Phase
Venous Thromboembolism
Drug: tinzaparin
Drug: acenocoumarol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Incidence of symptomatic recurrent venous thromboembolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of major bleeding [ Time Frame: 6 month treatment interval ] [ Designated as safety issue: Yes ]

Enrollment: 241
Study Start Date: January 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tinzaparin
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.
Drug: tinzaparin
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Other Names:
  • tinzaparin
  • innohep
Active Comparator: acenocoumarol
tinzaparin for 1 weeks followed by acenocoumarol for 6 months
Drug: acenocoumarol
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
Other Names:
  • Acenocoumarol
  • Vitamin K antagonists

Detailed Description:

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.

  Eligibility

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

Inclusion Criteria:

  • Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
  • either sex and over 18 years of age
  • referred to the Vascular Surgery Department of the hospital
  • onset of symptoms less than 2 weeks
  • documented by compression ultrasonography,

Exclusion Criteria:

  • received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
  • pulmonary embolism requiring thrombolytic therapy
  • Need of surgical thrombectomy or vena cava interruption
  • receiving oral anticoagulant treatment or antiplatelet agents for other conditions
  • contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
  • platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
  • severe renal failure necessitating dialysis
  • pregnancy
  • lumbar puncture within the previous 24 hours
  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: NCT00689520

Locations
Spain
Department of Vascular Surgery. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Vascular surgery service. Hospital Creu Roja de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
Sponsors and Collaborators
Hospital Universitari de Bellvitge
LEO Pharma
Investigators
Study Chair: Antoni Romera, MD Hospital Universitari de Bellvitge
Principal Investigator: Antoni Romera, MD Hospital Universitari de Bellvitge
Principal Investigator: Oriol Lapiedra, MD Hospital Creu Roja de l'Hospitalet
  More Information

No publications provided

Responsible Party: Romera, Antonio MD, Department of Vascular Surgery. Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT00689520     History of Changes
Other Study ID Numbers: CV1/01, CV1/01
Study First Received: May 28, 2008
Last Updated: June 2, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Venous thromboembolism
low molecular weight heparin
Vitamin K antagonist
Longterm

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Acenocoumarol
Anticoagulants
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014