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RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

8 maggio 2014 aggiornato da: Boehringer Ingelheim

RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2101

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • Australian Capital Territory
      • Garren, Australian Capital Territory, Australia
        • 1160.25.06108 Boehringer Ingelheim Investigational Site
    • New South Wales
      • Kogarah, New South Wales, Australia
        • 1160.25.06106 Boehringer Ingelheim Investigational Site
      • Lismore, New South Wales, Australia
        • 1160.25.06110 Boehringer Ingelheim Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia
        • 1160.25.06105 Boehringer Ingelheim Investigational Site
      • Toorak Gardens, South Australia, Australia
        • 1160.25.06107 Boehringer Ingelheim Investigational Site
      • Woodville, South Australia, Australia
        • 1160.25.06109 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 1160.25.06104 Boehringer Ingelheim Investigational Site
      • Clayton, Victoria, Australia
        • 1160.25.06102 Boehringer Ingelheim Investigational Site
      • Malvern, Victoria, Australia
        • 1160.25.06101 Boehringer Ingelheim Investigational Site
      • Ringwood East, Victoria, Australia
        • 1160.25.06103 Boehringer Ingelheim Investigational Site
      • Windsor, Victoria, Australia
        • 1160.25.06113 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • 1160.25.06111 Boehringer Ingelheim Investigational Site
  • Austria
      • Linz, Austria
        • 1160.25.04304 Boehringer Ingelheim Investigational Site
      • Wels, Austria
        • 1160.25.04303 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.25.04302 Boehringer Ingelheim Investigational Site
      • Wr. Neustadt, Austria
        • 1160.25.04301 Boehringer Ingelheim Investigational Site
  • Belgio
      • Brussels, Belgio
        • 1160.25.03207 UVC Brugmann
      • Genk, Belgio
        • 1160.25.03209 ZOL St. Jan
      • Gent, Belgio
        • 1160.25.03206 Campus Sint-Lucas
      • Gent, Belgio
        • 1160.25.03208 UZ Gent
      • Hasselt, Belgio
        • 1160.25.03202 Virga Jesseziekenhuis
      • Herentals, Belgio
        • 1160.25.03203 AZ Sint Elisabeth
      • Lanaken, Belgio
        • 1160.25.03205 Ziekenhuis Oost-Limburg
      • Leuven, Belgio
        • 1160.25.03201 UZ Gasthuisberg
  • Danimarca
      • Hellerup, Danimarca
        • 1160.25.04571 Boehringer Ingelheim Investigational Site
      • Hørsholm, Danimarca
        • 1160.25.04570 Boehringer Ingelheim Investigational Site
      • København NV, Danimarca
        • 1160.25.04573 Boehringer Ingelheim Investigational Site
      • København S, Danimarca
        • 1160.25.04574 Boehringer Ingelheim Investigational Site
      • Silkeborg, Danimarca
        • 1160.25.04575 Boehringer Ingelheim Investigational Site
  • Finlandia
      • Helsinki, Finlandia
        • 1160.25.35803 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finlandia
        • 1160.25.35802 Boehringer Ingelheim Investigational Site
      • Oulu, Finlandia
        • 1160.25.35801 Boehringer Ingelheim Investigational Site
      • Seinäjoki, Finlandia
        • 1160.25.35804 Boehringer Ingelheim Investigational Site
  • Francia
      • Amiens cedex 1, Francia
        • 1160.25.03304 Boehringer Ingelheim Investigational Site
      • Annecy, Francia
        • 1160.25.03307 Boehringer Ingelheim Investigational Site
      • La Rochelle, Francia
        • 1160.25.03305 Boehringer Ingelheim Investigational Site
      • Paris cedex 14, Francia
        • 1160.25.03301 Boehringer Ingelheim Investigational Site
      • Poitiers cedex, Francia
        • 1160.25.03306 Boehringer Ingelheim Investigational Site
      • Roubaix cedex, Francia
        • 1160.25.03303 Boehringer Ingelheim Investigational Site
      • Soyaux, Francia
        • 1160.25.03302 Boehringer Ingelheim Investigational Site
      • St Etienne cedex 2, Francia
        • 1160.25.03309 Boehringer Ingelheim Investigational Site
      • Strasbourg cedex 2, Francia
        • 1160.25.03308 Boehringer Ingelheim Investigational Site
  • Germania
      • Bad Mergentheim, Germania
        • 1160.25.04906 Caritaskrankenhaus
      • Erlangen, Germania
        • 1160.25.04910 F.-A.-Universität Erlangen-Nürnberg
      • Frankfurt, Germania
        • 1160.25.04904 Orthopädische Universitätsklinik
      • Garmisch-Partenkirchen, Germania
        • 1160.25.04902 Klinikum Garmisch-Partenkirchen
      • Halle/Saale, Germania
        • 1160.25.04911 Martin-Luther-Universität Halle-Wittenberg
      • Markgröningen, Germania
        • 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH
      • Rheinfelden, Germania
        • 1160.25.04901 Kreiskrankenhaus
      • Sommerfeld, Germania
        • 1160.25.04903 Hellmuth-Ulrici-Kliniken
      • Wiesbaden, Germania
        • 1160.25.04905 Aukammklinik
  • Italia
      • Bologna, Italia
        • 1160.25.03906 Boehringer Ingelheim Investigational Site
      • Parma, Italia
        • 1160.25.03905 Boehringer Ingelheim Investigational Site
      • Pavia, Italia
        • 1160.25.03901 Boehringer Ingelheim Investigational Site
      • Piacenza, Italia
        • 1160.25.03903 Boehringer Ingelheim Investigational Site
      • Reggio Emilia, Italia
        • 1160.25.03904 Boehringer Ingelheim Investigational Site
      • Treviso, Italia
        • 1160.25.03902 Boehringer Ingelheim Investigational Site
  • Olanda
      • Amsterdam, Olanda
        • 1160.25.03102 Boehringer Ingelheim Investigational Site
      • Hilversum, Olanda
        • 1160.25.03103 Boehringer Ingelheim Investigational Site
      • Hoofddorp, Olanda
        • 1160.25.03101 Boehringer Ingelheim Investigational Site
      • Nijmegen, Olanda
        • 1160.25.03104 Boehringer Ingelheim Investigational Site
      • Sittard, Olanda
        • 1160.25.03105 Boehringer Ingelheim Investigational Site
      • Zwolle, Olanda
        • 1160.25.03106 Boehringer Ingelheim Investigational Site
  • Polonia
      • Kielce, Polonia
        • 1160.25.04804 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.25.04806 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.25.04807 Boehringer Ingelheim Investigational Site
      • Warsaw, Polonia
        • 1160.25.04803 Boehringer Ingelheim Investigational Site
  • Repubblica Ceca
      • Brno-Bohunice, Repubblica Ceca
        • 1160.25.42004 Boehringer Ingelheim Investigational Site
      • Chomutov, Repubblica Ceca
        • 1160.25.42010 Boehringer Ingelheim Investigational Site
      • Havlickuv Brod, Repubblica Ceca
        • 1160.25.42009 Boehringer Ingelheim Investigational Site
      • Kladno, Repubblica Ceca
        • 1160.25.42002 Boehringer Ingelheim Investigational Site
      • Kolin, Repubblica Ceca
        • 1160.25.42006 Boehringer Ingelheim Investigational Site
      • Ostrava, Repubblica Ceca
        • 1160.25.42003 Boehringer Ingelheim Investigational Site
      • Plzen, Repubblica Ceca
        • 1160.25.42001 Boehringer Ingelheim Investigational Site
      • Pradubice, Repubblica Ceca
        • 1160.25.42007 Boehringer Ingelheim Investigational Site
      • Prague 8, Repubblica Ceca
        • 1160.25.42005 Boehringer Ingelheim Investigational Site
  • Spagna
      • Alcorcón (Madrid), Spagna
        • 1160.25.03405 Boehringer Ingelheim Investigational Site
      • Barcelona, Spagna
        • 1160.25.03403 Boehringer Ingelheim Investigational Site
      • Barcelona, Spagna
        • 1160.25.03411 Boehringer Ingelheim Investigational Site
      • Hospitalet (Barcelona), Spagna
        • 1160.25.03407 Boehringer Ingelheim Investigational Site
      • Jaén, Spagna
        • 1160.25.03409 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1160.25.03401 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1160.25.03402 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1160.25.03404 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1160.25.03406 Boehringer Ingelheim Investigational Site
      • Móstoles (Madrid), Spagna
        • 1160.25.03408 Boehringer Ingelheim Investigational Site
      • Valencia, Spagna
        • 1160.25.03410 Boehringer Ingelheim Investigational Site
  • Sud Africa
      • Bryanston, Sud Africa
        • 1160.25.02701 Boehringer Ingelheim Investigational Site
      • Randburg, Sud Africa
        • 1160.25.02703 Boehringer Ingelheim Investigational Site
      • Sandton, Sud Africa
        • 1160.25.02702 Boehringer Ingelheim Investigational Site
  • Svezia
      • Falköping, Svezia
        • 1160.25.04602 Boehringer Ingelheim Investigational Site
      • Göteborg, Svezia
        • 1160.25.04601 Boehringer Ingelheim Investigational Site
      • Halmstad, Svezia
        • 1160.25.04607 Boehringer Ingelheim Investigational Site
      • Kungälv, Svezia
        • 1160.25.04603 Boehringer Ingelheim Investigational Site
      • Lidköping, Svezia
        • 1160.25.04608 Boehringer Ingelheim Investigational Site
      • Linköping, Svezia
        • 1160.25.04605 Boehringer Ingelheim Investigational Site
      • Mölndal, Svezia
        • 1160.25.04604 Boehringer Ingelheim Investigational Site
      • Stockholm, Svezia
        • 1160.25.04610 Boehringer Ingelheim Investigational Site
      • Varberg, Svezia
        • 1160.25.04609 Boehringer Ingelheim Investigational Site
  • Ungheria
      • Budapest, Ungheria
        • 1160.25.03603 Boehringer Ingelheim Investigational Site
      • Békéscsaba, Ungheria
        • 1160.25.03607 Boehringer Ingelheim Investigational Site
      • Gyula, Ungheria
        • 1160.25.03601 Boehringer Ingelheim Investigational Site
      • Kecskemét, Ungheria
        • 1160.25.03604 Boehringer Ingelheim Investigational Site
      • Szeged, Ungheria
        • 1160.25.03602 Boehringer Ingelheim Investigational Site
      • Székesfehérvár, Ungheria
        • 1160.25.03605 Boehringer Ingelheim Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria

Inclusion criteria (selected):

  • Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement
  • Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

  • Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
  • Active malignant disease or current cytostatic treatment
  • Known severe renal insufficiency
  • Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) > 2x upper limit of normal
  • Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
  • Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control
  • Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran
  • Contraindications to enoxaparin
  • Participation in a clinical trial during the last 30 days

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: dabigatran etexilate 220 mg
220 mg once daily
Droga: dabigatran etexilate
150 mg once daily
Droga: dabigatran etexilate
220 mg once daily
Sperimentale: dabigatran etexilate 150 mg
150 mg once daily
Droga: dabigatran etexilate
150 mg once daily
Droga: dabigatran etexilate
220 mg once daily
Comparatore attivo: enoxaparin
40 mg once daily
Droga: enoxaparina
40 mg una volta al giorno

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Lasso di tempo: First administration until 6-10 days

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
First administration until 6-10 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Lasso di tempo: 3 months
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
3 months
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Lasso di tempo: First administration until 6-10 days
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Lasso di tempo: First administration until 6-10 days
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Lasso di tempo: First administration until 6-10 days
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Lasso di tempo: First administration until 6-10 days
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants With Pulmonary Embolism During Treatment Period
Lasso di tempo: First administration until 6-10 days
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants Who Died During Treatment Period
Lasso di tempo: First administration until 6-10 days
All cause death, as adjudicated by the VTE events committee
First administration until 6-10 days
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Lasso di tempo: First administration until 6-10 days

Major bleeding events were defined as

  • fatal
  • clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
  • clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
  • symptomatic retroperitoneal, intracranial, intraocular or intraspinal
  • requiring treatment cessation
  • leading to re-operation

Clinically-relevant was defined as

  • spontaneous skin hematoma greater than or equal to 25 cm²
  • wound hematoma greater than or equal to 100 cm²
  • spontaneous nose bleed lasting longer than 5 min
  • macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
  • spontaneous rectal bleeding (more than a spot on toilet paper)
  • gingival bleeding lasting longer than 5 min
  • any other bleeding event considered clinically relevant by the investigator

Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
First administration until 6-10 days
Blood Transfusion
Lasso di tempo: Day 1
Blood transfusion for treated and operated patients on Day of surgery.
Day 1
Volume di perdita di sangue
Lasso di tempo: Giorno 1
Volume di perdita di sangue per i pazienti trattati e operati durante l'intervento chirurgico.
Giorno 1
Analisi di laboratorio
Lasso di tempo: Prima somministrazione alla fine dello studio
Frequenza di pazienti con possibili anomalie clinicamente significative.
Prima somministrazione alla fine dello studio

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2004

Completamento primario (Effettivo)

1 maggio 2006

Date di iscrizione allo studio

Primo inviato

12 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2005

Primo Inserito (Stima)

15 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2014

Ultimo verificato

1 febbraio 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1160.25
  • 2004-001317-34 (Numero EudraCT: EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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