Overview

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

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Dabigatran
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.