Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

NCT ID: NCT01880216

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enoxaparin sodium

subcutaneous for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin

Group Type: ACTIVE_COMPARATOR

Enoxaparin sodium

Intervention Type: DRUG

subcutaneous for 7±2 days

Bemiprin sodium

Bemiparin sodium (LMWH) s.c. for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin

Group Type: EXPERIMENTAL

Bemiparin sodium

Intervention Type: DRUG

subcutaneous application daily for 7±2 days

Interventions

Bemiparin sodium

subcutaneous application daily for 7±2 days

Intervention Type: DRUG

Enoxaparin sodium

subcutaneous for 7±2 days

Intervention Type: DRUG

Other Intervention Names

LMWH; CAS 874-98-4; LMWH; CAS 73334-07-3

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berlin-Chemie AG Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Th Kaltwasser, Dr.

Role: STUDY_CHAIR

Berlin-Chemie AG

Locations

Unimed Ajara LLC

Batumi, , Georgia

Angiology and Vascular Surgery Academic Clinic

Tbilisi, , Georgia

Bokhua Clinic of Angiology and Heart Diseases

Tbilisi, , Georgia

G. Chapidze Emergency Cardiology Centre

Tbilisi, , Georgia

Aversi Clinic

Tbilisi, , Georgia

Regional State Budget Institution of Healthcare "Regional Clinical Hospital"

Barnaul, , Russia

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, , Russia

State Healthcare Institution "Republican Clinical hospital of the ministry of Health of Republic Tatarstan

Kazan', , Russia

State Budget Public Health Institution of Moscow "City Clinical Hospital # 1 n.a. N.I. Pirogov"

Moscow, , Russia

Federal Government Healthcare Institution "Hospital of the Russian Federation Internal Affairs Ministry in Moscow"

Moscow, , Russia

Federally Funded State Institution "Institute of Surgery n.a. A.V. Vishnevskiy of the Ministry of Healthcare of Russian Federation"

Moscow, , Russia

State-Financed Healthcare Institution of the Novosibirsk Region "City Clinical Hospital # 2"

Novosibirsk, , Russia

State Budgetary Institution of the Omsk Region "Regional Clinical Hospital"

Omsk, , Russia

State Independent Healthcare Institution of the Perm kray "City Clinical Hospital # 4"

Perm, , Russia

State Budget Institution of Hifger Professional Education "Rostov State Medical University" of the Ministry of the Russian Federation

Rostov-on-Don, , Russia

State Budgetary Institution of the Ryazan Region "Regional Clinical Cardiologic Dispensary"

Ryazan, , Russia

State Budget Institution "St.Petersburg Janelidze Research Institute of Emergency Medicine"

Saint Petersburg, , Russia

St. Petersburg State Public Health Institution "City Multi-field Hospital #2"

Saint Petersburg, , Russia

Nongovernmental Public Health Institution " Road Clinical Hospital" of Russian Railways

Saint Petersburg, , Russia

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, , Russia

St. Petersburg State Public Health Institution "City Hospital #26"

Saint Petersburg, , Russia

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, , Russia

State budgetary institution of higher professional education "Samara State Medical University"

Samara, , Russia

State Budget Public Health Institution of Yaroslavl region "Clinical hospital #10", Municipal Clinical Public Health Institution " Medical Unit of Novo-Yaroslavl Petroleum Refinery"

Yaroslavl, , Russia

State Budget Public Health Institution of Yaroslavl Region "Regional Clinical Hospital"

Yaroslavl, , Russia

Countries

Georgia; Russia

References

Suchkov IA, Martinez-Gonzalez J, Schellong SM, Garbade T, Falciani M; Bemiparin DVT Study Group. Comparison of Once-Daily Bemiparin with Twice-Daily Enoxaparin for Acute Deep Vein Thrombosis: A Multicenter, Open-Label, Randomized Controlled Trial. Clin Drug Investig. 2018 Feb;38(2):181-189. doi: 10.1007/s40261-017-0600-6.

Reference Type: DERIVED

PMID: 29214507 (View on PubMed)

Other Identifiers

Bemiparin

Identifier Type: -

Identifier Source: org_study_id