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

Total Knee Replacement Clinical Trial

Official title:

A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088358
• Other study ID #: CV-TRX-01
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2017
• Last updated: March 18, 2017
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2017
• Source: TeaRx LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Total Knee Replacement

Intervention

Drug:
• TeaRx

• Enoxaparin

Locations

Country	Name	City	State
Russian Federation	SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"	Kazan
Russian Federation	Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation	Moscow
Russian Federation	SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation	Moscow
Russian Federation	SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin	Moscow
Russian Federation	FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation	Nizhny Novgorod
Russian Federation	SBHI "City Clinical Hospital ? 4" of the city of Orenburg	Orenburg
Russian Federation	St. Petersburg State Institution of Health "City Hospital ? 2"	Saint Petersburg
Russian Federation	SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
TeaRx LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)		6 weeks following total knee replacement
Primary	Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)		6 weeks following total knee replacement
Primary	Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)		6 weeks following total knee replacement
Primary	venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)		6 weeks following total knee replacement
Primary	Non-VTE caused mortality (efficacy of the selected TeaRx dose)		6 weeks following total knee replacement
Primary	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	Incidence of bleeding (safety of selected TeaRx dose)	major and clinically relevant non-major bleeding	6 weeks following total knee replacement