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

May 28, 2008
June 2, 2008
January 2002
January 2005   (final data collection date for primary outcome measure)
Incidence of symptomatic recurrent venous thromboembolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00689520 on ClinicalTrials.gov Archive Site
Occurrence of major bleeding [ Time Frame: 6 month treatment interval ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thromboembolism
  • 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
  • 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
  • Experimental: tinzaparin
    tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.
    Intervention: Drug: tinzaparin
  • Active Comparator: acenocoumarol
    tinzaparin for 1 weeks followed by acenocoumarol for 6 months
    Intervention: Drug: acenocoumarol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00689520
CV1/01, CV1/01
No
Romera, Antonio MD, Department of Vascular Surgery. Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
LEO Pharma
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
Hospital Universitari de Bellvitge
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP