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Completed

NCT Number: NCT00168818

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

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.

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Key information

Conditions

Thromboembolism Arthroplasty, Replacement, Hip Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1160.48.06108 Canberra Hospital, Garren, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran Etexilate

Drug

daily dose 150 mg once daily, half a dose on the day of surgery

Enoxaparin

Drug

40 mg once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 15, 2005
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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