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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2005

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.

Intervention(s) in this Clinical Trial

• Drug: tinzaparin
  • tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: tinzaparin
  • tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.
• Active Comparator: acenocoumarol
  • tinzaparin for 1 weeks followed by acenocoumarol for 6 months

Primary Measures

• Incidence of symptomatic recurrent venous thromboembolism
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Occurrence of major bleeding
  • Time Frame: 6 month treatment interval
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital Universitari de Bellvitge

Overall Clinical Trial Officials and Contacts

Antoni Romera, MD Study Chair Hospital Universitari de Bellvitge  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689520

Study ID Number: CV1/01

ClinicalTrials.gov Identifier: NCT00689520

Health Authority: Spain: Spanish Agency of Medicines