RE-MODEL Dabigatran Etexilate 150mg or 220mg o.d vs. Enoxaparin 40mg o.d for Prevention of Thrombosis After Knee Surgery - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00168805

Purpose

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Condition	Intervention	Phase
Arthroplasty, Replacement, Knee Thromboembolism	Drug: "Dabigatran etexilate (oral, 150 mg once daily)" Drug: "Enoxaparin (subcutaneous, 40 mg once daily)" Drug: "Dabigatran etexilate (oral, 220 mg once daily)"	Phase III

MedlinePlus related topics: Knee Replacement

Drug Information available for: Dabigatran etexilate Dabigatran Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Total venous thromboembolic events (VTE) and all cause mortality during the treatment period. Total VTE is defined as the composite incidence of proximal and distal deep venous thrombosis (DVT), symptomatic DVT and pulmonary embolism (PE).

Secondary Outcome Measures:

Efficacy: Major VTE (proximal DVT and PE) and VTE related mortality proximal DVT total DVT symptomatic DVT PE death Safety: Bleeds blood loss + transfusion adverse events (AE) discontinuation due to AE laboratory physical exam.

Estimated Enrollment:	2101
Estimated Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria (selected):

Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement
Written Informed Consent

Exclusion criteria (selected):

Patients with an excessive risk of bleeding, for example because of history o f bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleedin g, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastri c / duodenal ulcer within the last 6 months treatment with anticoagulants withi n 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 A ST or ALT > 2x upper limit of normal
Recent unstable cardiovascular disease or history of myocardial infarction wit hin the last 3 months
Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control
Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran
Contraindications to enoxaparin
Participation in a clinical trial during the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168805

Show 101 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	1160.25
Study First Received:	September 12, 2005
Last Updated:	August 30, 2007
ClinicalTrials.gov Identifier:	NCT00168805
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases

Thromboembolism
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009