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-ES

Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Occurrence of confirmed composite endpoint of asymptomatic deep venous thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Secondary Objective: - Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events.<br>- Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death.;Primary end point(s): Number of patients with confirmed composite endpoint.;Timepoint(s) of evaluation of this end point: day 14

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of patients with composite venous thromboembolic events (VTE).;Timepoint(s) of evaluation of this end point: - day 1 to day 50 and day 1 to day 110