Trial | NCT00689520  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    241
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.
Study Started
Jan 31
2002
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Jun 03
2008
Estimate

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: 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: Vitamin K antagonists

tinzaparin Experimental

tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.

acenocoumarol Active Comparator

tinzaparin for 1 weeks followed by acenocoumarol for 6 months

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
No Results Posted