Status:
WITHDRAWN
Prevention of Thromboembolic Events in Total Knee Replacement Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Thrombotic Disorders
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)
Eligibility Criteria
Inclusion
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
- Body weight between 50 kg and 130 kg inclusive.
- Normal aPTT, PT, INR at screening
Exclusion
- History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).
- Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR \< 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C \>10%); Liver dysfunction (ALT/AST \>3 xULN or TBL \>2 x ULN); BMI ≥ 40 kg/m2
Key Trial Info
Start Date :
October 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03393481
Start Date
October 3 2018
End Date
April 17 2020
Last Update
October 8 2020
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