Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

NCT01880216 | Completed Phase 3

• 1 other identifier: Bemiparin
• Study Type: interventional
• Target: 312
• Locations: 2 countries
• Sites: 25

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.

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; DVT; Treatment; Low molecular weight heparin; Bemiparin; Enoxaparin

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with an improvement in thrombotic burden at Visit 3

  83±7 days

Secondary Outcomes (1)

• Incidence of symptomatic venous thromboembolic events (VTE)

  83±7 days

Other Outcomes (1)

• Treatment emergent adverse events (TEAEs)

  83±7 days

Study Arms (2)

Enoxaparin sodium

ACTIVE COMPARATOR

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

Drug: Enoxaparin sodium

Bemiprin sodium

EXPERIMENTAL

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

Drug: Bemiparin sodium

Interventions

Bemiparin sodium DRUG

subcutaneous application daily for 7±2 days

Also known as: LMWH; CAS 874-98-4

Bemiprin sodium

Enoxaparin sodium DRUG

subcutaneous for 7±2 days

Also known as: LMWH; CAS 73334-07-3

Enoxaparin sodium

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Males and females aged ≥18 years
• Patients who have given their written informed consent.

You may not qualify if:

• Specific
• 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
• 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
• 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
• Long-term treatment with vitamin K antagonists, i.e. for atrial fibrillation, myocardial infarction or cardiomyopathy
• Isolated distal calf vein thrombosis
• Isolated superficial vein thrombosis
• Any other symptomatic venous thromboembolism beside of DVT
• 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
• 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
• History of documented or suspected heparin-induced thrombocytopenia (HIT I and II) or platelet count less than 100,000 platelets per mm3
• Ischaemic stroke one month prior to enrolment
• 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.
• Uncontrolled arterial hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 105 mmHg.
• 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.

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (25)

Unimed Ajara LLC

Batumi, 6000, Georgia

Location

Angiology and Vascular Surgery Academic Clinic

Tbilisi, 0112, Georgia

Location

Bokhua Clinic of Angiology and Heart Diseases

Tbilisi, 0159, Georgia

Location

G. Chapidze Emergency Cardiology Centre

Tbilisi, 0159, Georgia

Location

Aversi Clinic

Tbilisi, 0177, Georgia

Location

Regional State Budget Institution of Healthcare "Regional Clinical Hospital"

Barnaul, Russia

Location

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, 664079, Russia

Location

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

Kazan', 420097, Russia

Location

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

Moscow, 117049, Russia

Location

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

Moscow, 127299, Russia

Location

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

Moscow, 305035, Russia

Location

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

Novosibirsk, 630051, Russia

Location

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

Omsk, 664111, Russia

Location

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

Perm, 614107, Russia

Location

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

Rostov-on-Don, 344022, Russia

Location

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

Ryazan, 117997, Russia

Location

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

Saint Petersburg, 192242, Russia

Location

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

Saint Petersburg, 194354, Russia

Location

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

Saint Petersburg, 195271, Russia

Location

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, 195427, Russia

Location

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

Saint Petersburg, 196247, Russia

Location

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, 197374, Russia

Location

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

Samara, 443099, Russia

Location

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

Yaroslavl, 150023, Russia

Location

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

Yaroslavl, 150062, Russia

Location

Related Publications (1)

• 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.

  PMID: 29214507 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Heparin, Low-Molecular-Weight; enoxaparin sodium

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Maria Th Kaltwasser, Dr.

  Berlin-Chemie AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

GE (5); RU (20)