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Deep Vein ThrombosisPhase 3NCT01880216

Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

A Phase 3 study testing Bemiparin sodium and Enoxaparin sodium in people with Deep Vein Thrombosis, run by Berlin-Chemie AG Menarini Group at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
Bemiparin sodium and Enoxaparin sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
25 sitesin 2 countries
Study dates
Jun 2013to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.
  • 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

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

Russia20 sites

  • Regional State Budget Institution of Healthcare "Regional Clinical Hospital"

    Barnaul

  • 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

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

    Kazan', 420097

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

    Moscow, 117049

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

    Moscow, 127299

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

    Moscow, 305035

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

    Novosibirsk, 630051

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

    Omsk, 664111

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

    Perm, 614107

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

    Rostov-on-Don, 344022

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

    Ryazan, 117997

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

    Saint Petersburg, 192242

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

    Saint Petersburg, 194354

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

    Saint Petersburg, 195271

  • 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

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

    Saint Petersburg, 196247

  • 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

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

    Samara, 443099

  • 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

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

    Yaroslavl, 150062

Other trials in Russia

Georgia5 sites

  • Unimed Ajara LLC

    Batumi, 6000

  • Angiology and Vascular Surgery Academic Clinic

    Tbilisi, 0112

  • Bokhua Clinic of Angiology and Heart Diseases

    Tbilisi, 0159

  • G. Chapidze Emergency Cardiology Centre

    Tbilisi, 0159

  • Aversi Clinic

    Tbilisi, 0177

Other trials in Georgia

About this study

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)

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.

Read the 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

Being tested
Bemiparin sodium, Enoxaparin sodium
Keywords
Deep vein thrombosis, DVT, Treatment, Low molecular weight heparin, Bemiparin, Enoxaparin
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bemiparin sodiumDrug

    Also called LMWH; CAS 874-98-4

    subcutaneous application daily for 7±2 days

  • Enoxaparin sodiumDrug

    Also called LMWH; CAS 73334-07-3

    subcutaneous for 7±2 days

Study groups in NCT01880216
Study groupRoleWhat they receive
Enoxaparin sodiumActive comparatorsubcutaneous for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
Receives: Drug: Enoxaparin sodium
Bemiprin sodiumExperimentalBemiparin sodium (LMWH) s.c. for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
Receives: Drug: Bemiparin sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 83±7 days

Secondary outcomes (1)

  1. Incidence of symptomatic venous thromboembolic events (VTE)

    Measured: 83±7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880216
Sponsor's protocol ID
Bemiparin
Status last verified
Feb 2016
First submitted
14 Jun 2013
Last updated
4 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29214507

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bemiparin sodium and Enoxaparin sodium in people with Deep Vein Thrombosis, run by Berlin-Chemie AG Menarini Group at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Russia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with an improvement in thrombotic burden at Visit 3 (time frame: 83±7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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