Prevention of blood clots following surgery for knee replacement

Phase 1

• Conditions: venous thromboembolism; MedDRA version: 20.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002925-39-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- 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.
- See full list in protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

- 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.
- See full list in protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified