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

Phase 2

Completed

Conditions: Arthroplasty, Replacement, Knee
Venous Thrombosis

Interventions: Drug: placebo
Drug: Dabigatran Etexilate

Registration Number: NCT00246025

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 512

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	matching placebo capsule, once a day, oral administration
Dabigatran etexilate 110 mg	Dabigatran Etexilate	Dabigatran etexilate 110 mg capsule, once a day, oral administration
Dabigatran etexilate 150 mg	Dabigatran Etexilate	Dabigatran etexilate 150 mg capsule, once a day, oral administration
Dabigatran etexilate 220 mg	Dabigatran Etexilate	Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.	2 weeks study medication	number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality	2 weeks	Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality
Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period	2 weeks	Number of participants who have Proximal DVT during treatment period
Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)	2 weeks	Number of Participants expressing DVT with symptoms
Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period	2 weeks	Number of participants who have Total DVT during treatment period
Number of Participants With Pulmonary Embolism During Treatment Period	2 weeks	Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.
Number of Participants Who Died During Treatment Period	2 weeks	All cause death, as adjudicated by the VTE events committee.
Number of Participants With Bleeding Events During Treatment Period	2 weeks	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.
Blood Transfusion	Day 0	Blood transfusion for treated and operated patients on Day of surgery.
Volume of Blood Loss	Day 0	Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses	First administration to end of study	Frequency of patients with possible clinically significant abnormalities.

Trial Locations

Locations (38): 1160.50.030 Boehringer Ingelheim Investigational Site
🇯🇵
Okayama, Okayama, Japan
1160.50.015 Boehringer Ingelheim Investigational Site
🇯🇵
Osaka, Osaka, Japan
1160.50.016 Boehringer Ingelheim Investigational Site
🇯🇵
Osaka, Osaka, Japan
1160.50.011 Boehringer Ingelheim Investigational Site
🇯🇵
Iida, Nagano, Japan
1160.50.029 Boehringer Ingelheim Investigational Site
🇯🇵
Shinjuku-ku,Tokyo, Japan
1160.50.027 Boehringer Ingelheim Investigational Site
🇯🇵
Kawasaki, Kanagawa, Japan
1160.50.014 Boehringer Ingelheim Investigational Site
🇯🇵
Osaka, Osaka, Japan
1160.50.026 Boehringer Ingelheim Investigational Site
🇯🇵
Hiroshima, Hiroshima, Japan
1160.50.002 Boehringer Ingelheim Investigational Site
🇯🇵
Sapporo, Hokkaido, Japan
1160.50.034 Boehringer Ingelheim Investigational Site
🇯🇵
Sendai, Miyagi, Japan
1160.50.023 Boehringer Ingelheim Investigational Site
🇯🇵
Tomigusuku, Okinawa, Japan
1160.50.040 Boehringer Ingelheim Investigational Site
🇯🇵
Tsukuba , Ibaraki, Japan
1160.50.045 Boehringer Ingelheim Investigational Site
🇯🇵
Izunokuni,Shizuoka, Japan
1160.50.022 Boehringer Ingelheim Investigational Site
🇯🇵
Kagoshima, Kagoshima, Japan
1160.50.043 Boehringer Ingelheim Investigational Site
🇯🇵
Shizuoka, Shizuoka, Japan
1160.50.031 Boehringer Ingelheim Investigational Site
🇯🇵
Saga, Saga, Japan
1160.50.033 Boehringer Ingelheim Investigational Site
🇯🇵
Osaka, Osaka, Japan
1160.50.025 Boehringer Ingelheim Investigational Site
🇯🇵
Sasebo, Nagasaki, Japan
1160.50.001 Boehringer Ingelheim Investigational Site
🇯🇵
Eniwa, Hokkaido, Japan
1160.50.024 Boehringer Ingelheim Investigational Site
🇯🇵
Izumisano, Osaka, Japan
1160.50.032 Boehringer Ingelheim Investigational Site
🇯🇵
Kawasaki, Kanagawa, Japan
1160.50.037 Boehringer Ingelheim Investigational Site
🇯🇵
Kurume ,Fukuoka, Japan
1160.50.036 Boehringer Ingelheim Investigational Site
🇯🇵
Matsue, Shimane, Japan
1160.50.042 Boehringer Ingelheim Investigational Site
🇯🇵
Miyazaki, Miyazaki, Japan
1160.50.028 Boehringer Ingelheim Investigational Site
🇯🇵
Musashimurayama, Tokyo, Japan
1160.50.041 Boehringer Ingelheim Investigational Site
🇯🇵
Kitakyusyu, Fukuoka, Japan
1160.50.013 Boehringer Ingelheim Investigational Site
🇯🇵
Kyoto, Kyoto, Japan
1160.50.005 Boehringer Ingelheim Investigational Site
🇯🇵
Obihiro, Hokkaido, Japan
1160.50.021 Boehringer Ingelheim Investigational Site
🇯🇵
Omura, Nagasaki, Japan
1160.50.009 Boehringer Ingelheim Investigational Site
🇯🇵
Sagamihara, Kanagawa, Japan
1160.50.004 Boehringer Ingelheim Investigational Site
🇯🇵
Sapporo, Hokkaido, Japan
1160.50.044 Boehringer Ingelheim Investigational Site
🇯🇵
Sumida-ku, Tokyo, 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
1160.50.039 Boehringer Ingelheim Investigational Site
🇯🇵
Koshigaya,Saitama, Japan
1160.50.038 Boehringer Ingelheim Investigational Site
🇯🇵
Kurume ,Fukuoka, Japan
1160.50.020 Boehringer Ingelheim Investigational Site
🇯🇵
Sasebo, Nagasaki, Japan