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Completed

NCT Number: NCT00152971

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1160.24.02031 University of Alberta Hospital, Edmonton, Alberta, Canada

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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

  • Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
  • Male or female 18 years of age or older.
  • Patients weighing at least 40 kg.
  • Written informed consent prior to the start of study participation.

Exclusion criteria

EXCLUSION CRITERIA

  • History of bleeding diathesis.
  • Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
  • Major surgery or trauma (e.g. hip fracture) within the last 3 months.
  • Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months.
  • Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.

Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.

  • Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
  • History of VTE or pre-existing condition requiring anticoagulant therapy.
  • Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
  • Gastric or duodenal ulcer within the last 6 months.
  • Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery).
  • Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
  • Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.

Treatment and study plan

Dabigatran Dose 1 - day 2 to completion

Drug

low dose regimen taken once daily

Dabigatran Dose 1 - day 1

Drug

low dose regimen taken once daily

Dabigatran Dose 2 - day 2 to completion

Drug

high dose regimen taken once daily

Dabigatran Dose 2 - day 1

Drug

high dose regimen taken once daily

Enoxaparin

Drug

30 mg subcutaneously twice daily

Primary outcomes

  1. Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

    Time frame: First administration until 12-15 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. Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

    Time frame: First administration until 12-15 days

    Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

  2. Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

    Time frame: First administration until 12-15 days

    Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

  3. Number of Participants With Total Deep Vein Thrombosis During Treatment Period

    Time frame: First administration until 12-15 days

    Total Deep Vein Thrombosis as adjudicated by the VTE events committee

  4. Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

    Time frame: First administration until 12-15 days

    Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

  5. Number of Participants With Pulmonary Embolism During Treatment Period

    Time frame: First administration until 12-15 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. Number of Participants Who Died During Treatment Period

    Time frame: First administration until 12-15 days

    All cause death, as adjudicated by the VTE events committee

  7. Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

    Time frame: 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).

  8. Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

    Time frame: First administration until 12-15 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 12, 2005
Registry last updated
May 5, 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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