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

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Completed

CT.gov ID

NCT00689520

Collaborator

LEO Pharma (Industry)

241

Enrollment

Locations

Arms

Duration (Months)

120.5

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: tinzaparin Drug: acenocoumarol	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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: 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: Vitamin K antagonists

Arm

Intervention/Treatment

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:

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:

Vitamin K antagonists

Outcome Measures

Primary Outcome Measures

Incidence of symptomatic recurrent venous thromboembolism [12 months]

Secondary Outcome Measures

Occurrence of major bleeding [6 month treatment interval]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vascular surgery service. Hospital Creu Roja de l'Hospitalet	L'Hospitalet de Llobregat	Barcelona	Spain	08906
2	Department of Vascular Surgery. Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907