A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

Boehringer Ingelheim512 enrolled

Overview

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

512

Conditions

Arthroplasty, Replacement, Knee Venous Thrombosis

Interventions

Dabigatran etexilateDRUG

Dabigatran etexilate 110 mg capsule, once a day, oral administration

Dabigatran etexilateDRUG

Dabigatran etexilate 150 mg capsule, once a day, oral administration

Dabigatran EtexilateDRUG

Dabigatran etexilate 220 mg capsule, once a day, oral administration

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion criteria Inclusion criteria 1. Patients scheduled to undergo a primary, unilateral elective total knee replacement 2. Male or Female 20 years of age or order 3. Patients weighing at least 40 kg 4. Written informed consent prior to the start of study participation Exclusion criteria Exclusion criteria 1. History of bleeding diathesis 2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding 3. Major surgery or trauma (e.g. hip fracture) within the last 3 months 4. 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 5. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history 6. Condition requiring anti-coagulant therapy 7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease 8. Patients with a history of clinically significant renal diseases or with elevated creatinine values

Locations (38)

Outcomes

Primary Outcomes

Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.

number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality

Time frame: 2 weeks study medication

Secondary Outcomes

Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality

Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality

Time frame: 2 weeks

Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Proximal DVT during treatment period

Time frame: 2 weeks

Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)

Number of Participants expressing DVT with symptoms

Time frame: 2 weeks

Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Total DVT during treatment period

Time frame: 2 weeks

Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.

Time frame: 2 weeks

Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee.

Data from ClinicalTrials.gov

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1160.50.001 Boehringer Ingelheim Investigational Site

Eniwa, Hokkaido, Japan

1160.50.018 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

1160.50.008 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, Japan

1160.50.006 Boehringer Ingelheim Investigational Site

Hirosaki, Aomori, Japan

1160.50.026 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

1160.50.011 Boehringer Ingelheim Investigational Site

Iida, Nagano, Japan

1160.50.024 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, Japan

1160.50.045 Boehringer Ingelheim Investigational Site

Izunokuni,Shizuoka, Japan

1160.50.022 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, Japan

1160.50.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

...and 28 more locations

Number of Participants With Bleeding Events During Treatment Period

Major bleeding events were defined as * fatal * clinically overt associated with loss of haemoglobin \>=2g/dL 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 \>=25 cm² * wound hematoma \>=100 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding (more than a spot on toilet paper) * gingival bleeding \>5 min * any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Time frame: 2 weeks