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Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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ClinicalTrials.gov Identifier: NCT00168818
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : December 20, 2010
Last Update Posted : May 19, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Condition or disease Intervention/treatment Phase
Thromboembolism Arthroplasty, Replacement, Hip Drug: dabigatran etexilate Drug: enoxaparin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Study Start Date : November 2004
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: dabigatran etexilate 75 mg
daily dose 150 mg once daily, half a dose on the day of surgery
 Drug: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Experimental: dabigatran etexilate 110 mg
daily dose 220 mg once daily, half a dose on the day of surgery
 Drug: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Active Comparator: enoxaparin
40 mg once daily
 Drug: enoxaparin
40 mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period [ Time Frame: First administration until 31-38 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.



Secondary Outcome Measures :
  1. Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period [ Time Frame: First administration until 31-38 days ]
    Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

  2. Proximal Deep Vein Thrombosis During Treatment Period [ Time Frame: First administration until 31-38 days ]
    Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

  3. Total Deep Vein Thrombosis During Treatment Period [ Time Frame: First administration until 31-38 days ]
    Total Deep Vein Thrombosis as adjudicated by the VTE events committee

  4. Symptomatic Deep Vein Thrombosis During Treatment Period [ Time Frame: First administration until 31-38 days ]
    Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

  5. Pulmonary Embolism During Treatment Period [ Time Frame: First administration until 31-38 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

  6. Death During Treatment Period [ Time Frame: First administration until 31-38 days ]
    All cause death, as adjudicated by the VTE events committee

  7. Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period [ Time Frame: end of treatment to day 91±7 ]
    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).

  8. Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period [ Time Frame: First administration until 31-38 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.


  9. Blood Transfusion [ Time Frame: Day 1 ]
    Blood transfusion for treated and operated patients on Day of surgery.

  10. Volume of Blood Loss [ Time Frame: Day 1 ]
    Volume of blood loss for treated and operated patients during surgery.

  11. Laboratory Analyses [ Time Frame: First administration to end of study ]
    Frequency of patients with possible clinically significant abnormalities.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Inclusion criteria (selected):

  • Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip 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, 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 AST or 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 potential and are not practising or do not plan to continue practising acceptable methods of birth control
  • Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
  • Contraindications to enoxaparin
  • Participation in a clinical trial during the last 30 days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168818


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00168818    
Other Study ID Numbers: 1160.48
2004-001988-21 ( EudraCT Number: EudraCT )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: December 20, 2010
Last Update Posted: May 19, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Dabigatran
Anticoagulants
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors