Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-09-30

Brief Summary

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To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:

* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
* Incidence of DVT (total, proximal, distal)
* Incidence of nonfatal PE
* Incidence of symptomatic VTE (DVT, PE)
* VTE caused mortality
* Non-VTE caused mortality
* Incidence of all hemorrhagic complications
* Incidence of major and clinically relevant non-major bleeding
* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results

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Detailed Description

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Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TeaRx 50 mg

TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days)

Group Type EXPERIMENTAL

TeaRx

Intervention Type DRUG

TeaRx 100 mg

TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)

Group Type EXPERIMENTAL

TeaRx

Intervention Type DRUG

TeaRx 150 mg

TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)

Group Type EXPERIMENTAL

TeaRx

Intervention Type DRUG

Enoxaparin

Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Interventions

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TeaRx

Intervention Type DRUG

Enoxaparin

Intervention Type DRUG

Other Intervention Names

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TeaRxaban Clexane ®

Eligibility Criteria

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Inclusion Criteria

* Male or female, age ≥ 18 years;
* Planned total knee replacement surgery;
* Signed informed consent form;
* Willing to comply with the protocol;
* Willing to use adequate contraception during the trial.

Exclusion Criteria

* Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
* History of venous thrombosis of any location or PE
* History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
* History of evident coagulopathy or in a relative
* Congenital thrombophilia
* Bleeding within 6 months of screening; increased risk of bleeding
* BMI less than 18,5 or more than 40 kg/m2
* Systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg registered twice within 15-30 minutes
* Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
* Platelets \< 100 000/mm3
* Clinical significant abnormalities of APTT and/or INR
* GFR \< 30 ml/min/1.73 m2
* ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No