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

NCT03088358 | Completed Phase 2

• 1 other identifier: CV-TRX-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (6)

• Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

• Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

• Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

• venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

• Non-VTE caused mortality (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

• AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)

  6 weeks following total knee replacement

Secondary Outcomes (1)

• Incidence of bleeding (safety of selected TeaRx dose)

  6 weeks following total knee replacement

Study Arms (4)

TeaRx 50 mg

EXPERIMENTAL

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

Drug: TeaRx

TeaRx 100 mg

EXPERIMENTAL

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

Drug: TeaRx

TeaRx 150 mg

EXPERIMENTAL

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

Drug: TeaRx

Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Interventions

TeaRx DRUG

Also known as: TeaRxaban

TeaRx 100 mg; TeaRx 150 mg; TeaRx 50 mg

Enoxaparin DRUG

Also known as: Clexane ®

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TeaRx LLC: lead

Study Sites (8)

SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"

Kazan', 420064, Russia

Location

Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation

Moscow, 105203, Russia

Location

SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation

Moscow, 119435, Russia

Location

SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin

Moscow, 125284, Russia

Location

FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation

Nizhny Novgorod, 603155, Russia

Location

SBHI "City Clinical Hospital № 4" of the city of Orenburg

Orenburg, 460000, Russia

Location

St. Petersburg State Institution of Health "City Hospital № 2"

Saint Petersburg, 194354, Russia

Location

SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov

Yaroslavl, 150003, Russia

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mikhail N. Zamyatin, Prof.

  Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 23, 2017
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)