Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

NCT ID: NCT01184989

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-04-30

Brief Summary

To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

Conditions

Arthroplasty, Replacement; Prevention of Venous Thromboembolism; Moderate Renal Impairment (CrCl 30-50 mL/Min)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dabigatran etexilate

open label, once daily dose approved by EMEA and Health Canada

Group Type: OTHER

Dabigatran etexilate

Intervention Type: DRUG

once daily approved dose by EMEA and Health Canada

Interventions

Dabigatran etexilate

once daily approved dose by EMEA and Health Canada

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients scheduled for primary unilateral elective total knee or hip replacement, male or female being 18 years or older

2. Moderate renal impairment (CrCl 30-50 mL/min)

3. Written informed consent

4. Caucasian patients

Exclusion Criteria

1. Patients weighing less than 40 kg.

2. Patients requiring chronic treatment with anticoagulants (e.g. vitamin K antagonists; e.g. patients with atrial fibrillation, patients with artificial heart valves, etc.).

3. Patients who in the investigator's judgment were perceived as having an excessive risk of bleeding, for example:

Constitutional or acquired coagulation disorders

History of bleeding diathesis

Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 3 months of enrolment

Major surgery or trauma (e.g. hip fracture) within 3 months of enrolment

History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100 000 cells/microliter at randomization

Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm

Any arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities

Presence of malignant neoplasms at higher risk of bleeding

Known or suspected oesophageal varices

Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days

Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or non-steroidal anti-inflammatory drug (NSAID) with t1/2>12 hours within 7 days prior to hip or knee replacement surgery OR anticipated need while the patient was receiving study medication and prior to 24 hours after the last administration of study medication (COX-2 selective inhibitors are allowed) because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period

4. Recent unstable cardiovascular disease (in the investigator's opinion) such as uncontrolled hypertension, that was ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment.

5. Ongoing treatment for VTE.

6. Liver disease expected to have any potential impact on survival (i.e. hepatitis B or C, cirrhosis) or ALT/AST >3x upper limit of normal range (ULN). This did not include Gilbert's syndrome or hepatitis A with complete recovery.

7. Known severe renal insufficiency (CrCl <30 mL/min) and patients with mild renal insufficiency (CrCl >50 mL/min) or normal renal function.

8. Planned anaesthesia with post-operative indwelling epidural catheters.

9. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent), who were:

Pregnant

Nursing

Of child-bearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included intrauterine device; oral, implantable or injectable contraceptives and surgical sterility

10. Hypersensitivity to dabigatran etexilate or to any of excipients.

11. Participation in a clinical trial within 30 days of enrolment.

12. Known alcohol or drug abuse which would interfere with completion of the study; patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration.

13. Previous participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1160.86.43001 Boehringer Ingelheim Investigational Site

Graz, , Austria

1160.86.43003 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1160.86.01001 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

1160.86.01002 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

1160.86.01003 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

1160.86.42002 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1160.86.35801 Boehringer Ingelheim Investigational Site

Jyväskylä, , Finland

1160.86.31002 Boehringer Ingelheim Investigational Site

Hilversum, , Netherlands

1160.86.46002 Boehringer Ingelheim Investigational Site

Hässleholm, , Sweden

1160.86.46001 Boehringer Ingelheim Investigational Site

Mölndal, , Sweden

Countries

Austria; Canada; Czechia; Finland; Netherlands; Sweden

Other Identifiers

2010-018723-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.86

Identifier Type: -

Identifier Source: org_study_id