NCT01880216

Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

A Multinational, Multicentre, Randomized, Open, Parallel Group Study on the Efficacy and Safety of Bemiparin Sodium (LMWH) Compared to Enoxaparin Sodium (LMWH) in the Treatment of Acute Deep Vein Thrombosis (DVT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Berlin-Chemie AG Menarini Group · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when a thrombus forms in one of the large veins, usually in the lower limbs, leading to either partial or complete blocked circulation. The condition may progress to severe health complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and effective manner. The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and pulmonary embolism in the short term and to prevent recurrent events in the long-term. Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also increases the risk for major hemorrhage. This trial aims to optimize the current medical knowledge on the effectiveness and safety of two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein thrombosis.

Detailed description

The aim of this study is to demonstrate the therapeutic non-inferiority of bemiparin sodium (LMWH) versus enoxaparin sodium (LMWH) during a 7±2 days treatment period and a follow up of 11 weeks observation period. Primary endpoint: The percentage of patients with an improvement in thrombotic burden at Visit 3 (Day 83) defined as a ≥4-point reduction in thrombus score (or at least halving the thrombus score, when the total score is ≤ 6), without confirmed symptomatic extension of recurrence of DVT, confirmed symptomatic PE, or VTE-related death at Visit 3 (Day 83 / Month 3), as measured by complete compression ultrasound (cCUS) by Duplex sonography according to a standardized protocol. Secondary endpoint: The secondary efficacy endpoints are defined as the: • Incidence of symptomatic venous thromboembolic events (VTE) at Visit 3 (Day 83: * Recurrent DVT * Pulmonary embolism Incusion criteria: Patients with acute deep-vein thrombosis of the leg (DVT) with symptoms of less than 14 days, confirmed by complete compression ultrasound (cCUS) within 48 hours prior study start. Patients who have given their signed declaration of consent and data protection declaration Males and females aged 18 years

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Bemiparin sodium	subcutaneous application daily for 7±2 days
DRUG	Enoxaparin sodium	subcutaneous for 7±2 days

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-01-01
• Completion: 2015-05-01
• First posted: 2013-06-18
• Last updated: 2016-02-04

Locations

25 sites across 2 countries: Georgia, Russia