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

TeaRx

Status and phase: Completed; Phase 2

Conditions: Total Knee Replacement

Treatments: Drug: Enoxaparin; Drug: TeaRx

Study type: Interventional

Funder types: Industry

Identifiers

NCT03088358

CV-TRX-01

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

TeaRx 50 mg

Experimental group

Description:

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

Treatment:

Drug: TeaRx

TeaRx 100 mg

Experimental group

Description:

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

Treatment:

Drug: TeaRx

TeaRx 150 mg

Experimental group

Description:

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

Treatment:

Drug: TeaRx

Enoxaparin

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin