Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

Deep Vein Thrombosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880216
• Other study ID #: Bemiparin
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2013
• Last updated: February 3, 2016
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Berlin-Chemie AG Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationGeorgia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. 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 h prior study starting .

2. Males and females aged =18 years

3. Patients who have given their written informed consent.

Exclusion Criteria:

Specific

1. History and presence of familial bleeding diathesis, presence of active bleeding contraindicating anticoagulant therapy, as well as presence of clinically relevant coagulation - and clotting factor disorder,and thrombocytopenia

2. Patients having undergone thrombectomy, having had insertion of a caval filter or who were treated with a fibrinolytic agent to treat the current episode of DVT

3. Treatment with heparin (fractionated or unfractionated), fondaparinux or vitamin K antagonist or warfarin for treatment of DVT for more than 48 h prior to enrolment

4. Long-term treatment with vitamin K antagonists, i.e. for atrial fibrillation, myocardial infarction or cardiomyopathy

5. Isolated distal calf vein thrombosis

6. Isolated superficial vein thrombosis

7. Any other symptomatic venous thromboembolism beside of DVT

8. Known hypersensitivity to heparin (including other pig-derived substances), to the study medications and heparin-derivatives including other LMWHs, warfarin and/or to the active ingredient or any excipient of the study medications

9. Concurrent treatment with platelet function inhibitors (such as acetylsalicylic acid, ticlopidine, clopidogrel, NSAID), fibrinolytic agents and other anticoagulant agents, Glycoprotein IIb/IIIa receptor- antagonists, nitro-glycerine iv, systemic glucocorticoids, penicillin in high doses, dextran, ascorbic acid, digitalis, tetracycline, medical products that could increase the potassium plasma level

10. History of documented or suspected heparin-induced thrombocytopenia (HIT I and II) or platelet count less than 100,000 platelets per mm3

11. Ischaemic stroke one month prior to enrolment

12. History of or active intracranial disorder (cerebral vascular aneurysm, arterio-venous malformation or cerebral neoplasm), history of haemorrhagic stroke or other intracranial bleeding 6 months prior to enrolment, active haemorrhage or increased risk of bleeding due to impaired haemostatics or organ lesion (e.g. peptic ulcer, hepatic failure, haemorrhagic stroke, macroscopic visible urogenital bleeding, cerebral vascular aneurysm or cerebral neoplasm) 1 month prior to enrolment.

13. Uncontrolled arterial hypertension: systolic blood pressure > 200 mmHg and diastolic blood pressure > 105 mmHg.

14. Severe impairment of pancreas function, history of gastro-duodenal ulcer disease, nephrolithiasis and/or ureterolithiasis, choroid and retinal vascular disease, suspected vascular retinopathy, vitreous haemorrhage or other intraocular bleedings, or any organic lesion with an increased risk of bleeding.

15. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, hepatic cirrhosis, hepatic encephalopathy) or liver enzymes (ALT and/or AST) > 5x ULN.

and others

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Bemiparin sodium
subcutaneous application daily for 7±2 days
• Enoxaparin sodium
subcutaneous for 7±2 days

Locations

Country	Name	City	State
Georgia	Unimed Ajara LLC	Batumi
Georgia	Angiology and Vascular Surgery Academic Clinic	Tbilisi
Georgia	Aversi Clinic	Tbilisi
Georgia	Bokhua Clinic of Angiology and Heart Diseases	Tbilisi
Georgia	G. Chapidze Emergency Cardiology Centre	Tbilisi
Russian Federation	Regional State Budget Institution of Healthcare "Regional Clinical Hospital"	Barnaul
Russian Federation	Federal State Budgetary Institution "Scientific Center of Reconstructive and Restorative Surgery" under Siberian Branch of the Russian Academy of Medical Sciences on the clinical base of State Institution of Healthcare, Irkutsk Regional Clinical Hospital	Irkutsk
Russian Federation	State Healthcare Institution "Republican Clinical hospital of the ministry of Health of Republic Tatarstan	Kazan
Russian Federation	Federal Government Healthcare Institution "Hospital of the Russian Federation Internal Affairs Ministry in Moscow"	Moscow
Russian Federation	Federally Funded State Institution "Institute of Surgery n.a. A.V. Vishnevskiy of the Ministry of Healthcare of Russian Federation"	Moscow
Russian Federation	State Budget Public Health Institution of Moscow "City Clinical Hospital # 1 n.a. N.I. Pirogov"	Moscow
Russian Federation	State-Financed Healthcare Institution of the Novosibirsk Region "City Clinical Hospital # 2"	Novosibirsk
Russian Federation	State Budgetary Institution of the Omsk Region "Regional Clinical Hospital"	Omsk
Russian Federation	State Independent Healthcare Institution of the Perm kray "City Clinical Hospital # 4"	Perm
Russian Federation	State Budget Institution of Hifger Professional Education "Rostov State Medical University" of the Ministry of the Russian Federation	Rostov-on-Don
Russian Federation	State Budgetary Institution of the Ryazan Region "Regional Clinical Cardiologic Dispensary"	Ryazan
Russian Federation	Federal State Budgetary Institution "Russian Center of Emergency and Radiation Medicine n.a. A.M. Nikiforov" of the Ministry of Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters	Saint-Petersburg
Russian Federation	Nongovernmental Public Health Institution " Road Clinical Hospital" of Russian Railways	Saint-Petersburg
Russian Federation	St. Petersburg State Public Health Institution "City Hospital #26"	Saint-Petersburg
Russian Federation	St. Petersburg State Public Health Institution "City Multi-field Hospital #2"	Saint-Petersburg
Russian Federation	State Budget Institution "St.Petersburg Janelidze Research Institute of Emergency Medicine"	Saint-Petersburg
Russian Federation	State Educational Institution of Additional Professional Education "St.Petersburg Medical Academy of Postgraduate Education of Federal Agency for Health Care and Social Development", Chair of cardiovascular surgery	Saint-Petersburg
Russian Federation	State budgetary institution of higher professional education "Samara State Medical University"	Samara
Russian Federation	State Budget Public Health Institution of Yaroslavl region "Clinical hospital #10", Municipal Clinical Public Health Institution " Medical Unit of Novo-Yaroslavl Petroleum Refinery"	Yaroslavl
Russian Federation	State Budget Public Health Institution of Yaroslavl Region "Regional Clinical Hospital"	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Berlin-Chemie AG Menarini Group

Countries where clinical trial is conducted

Georgia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment emergent adverse events (TEAEs)		83±7 days	Yes
Primary	Percentage of patients with an improvement in thrombotic burden at Visit 3		83±7 days	No
Secondary	Incidence of symptomatic venous thromboembolic events (VTE)		83±7 days	Yes