Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

NCT01629381 | Completed Phase 2 Results DMC

• 1 other identifier: 2010-024338-43
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 9

Brief Summary

Study Objective: To assess the value of Rivaroxaban for the prevention of venous thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of reference. Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of the type and duration of the procedure, will be eligible for the study. Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two arms:

• (R-7d) Rivaroxaban (10 mg od os) for 7 days
• (PL-7d) Placebo for 7 days. Follow-up: 3-month period after the randomization Standard of Reference:Placebo will be the standard of reference in accordance to international guidelines Study length May 2012-December 2012 Total patients number: 500 patients Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at least one of the following events, objectively proven (by means of CCDU; multi-slice chest TC-angio; autopsy, if necessary, or clinical ground):
• All-cause mortality
• Symptomatic VTE
• Asymptomatic proximal DVT Secondary Efficacy End-point:
• Combined incidence of all DVT plus symptomatic PE Primary Safety End-point: Incidence of major bleedings. Secondary Safety End-point: Overall incidence of bleeding

Conditions

Venous Thromboembolism; Haemorrhage

Keywords

knee arthroscopy; venous thromboembolism; prevention

Outcome Measures

Primary Outcomes (2)

• Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality

  During the scheduled visit in case of suspected DVT a bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU will be performed if the patients develop symptoms or signs suggestive of venous thromboembolism earlier; in case of suspected PE a multi-slice chest TC-angio is arranged; in case of death for all cause autoptic findings are requested or, if necessary, clinical ground is considered. A follow-up visit is planned 3-month period after the randomization.

  3-month period

• Major Bleedings

  Major bleeding include: clinically overt haemorrhage associated with haemoglobin drop of at least 2 g/L or requiring the transfusion of two or more units of packed red-blood cells; retroperitoneal or intracranial events; bleeding requiring re-intervention; and hemarthrosis with a joint drainage of more than 450 millilitres of blood.

  3 months

Secondary Outcomes (2)

• Combined Incidence of All DVT Plus Symptomatic PE

  3 months

• Overall Incidence of Bleeding

  3 months

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Oral Rivaroxaban 10 mg od for 7 days

Drug: Rivaroxaban

Placebo

PLACEBO COMPARATOR

oral placebo od for 7 days

Drug: placebo

Interventions

Rivaroxaban DRUG

10 mg os once daily for 1 week

Also known as: Xarelto

Rivaroxaban

placebo DRUG

10 mg os once daily for 1 week

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patient (18 years and older)
• Knee arthroscopy not combined with open surgery.
• Patients eligible for surgical treatment.
• Patients are willing and able to continue study participation to ensure completion of all procedures and observations required by the study.
• Written informed consent

You may not qualify if:

• Diagnostic arthroscopy
• Patients concomitantly treated systemically with strong concurrent CYP3A4 and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors.
• Hypersensitivity to the active substance or to any of the excipients of study drug
• Pregnant women or breast-feeding.
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
• Known thrombophilia (hereditary or acquired)
• Mandatory anticoagulation.
• Known severe bleeding tendency
• Clinically significant active bleeding.
• Severe renal failure (GFR\<30mL/min/1.73m2)
• Patients participating in another clinical trial.
• Recent mayor surgery (6 to 12 weeks)

Sponsors & Collaborators

• University of Padova: lead

Study Sites (9)

Thrombosis Center & Knee Arthroscopy and Sports Medicine Center, Humanitas Clinical Insitute

Rozzano, Milano, 20089, Italy

Location

Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova

Genova, Italy

Location

Department of Internal Medicine, University Hospital of Napoli

Napoli, Italy

Location

Department of Orthopaedics and Traumatology, University Hospital of Pavia

Pavia, Italy

Location

Section of Internal and Cardiovascular Medicine, Department of Internal Medicine, University of Perugia

Perugia, 06123, Italy

Location

Department of Internal Medicine, Hospital of Piacenza

Piacenza, Italy

Location

Unit of Angiology, Department of Internal Medicine, Azienda Ospedaliera - IRCCS

Reggio Emilia, 42100, Italy

Location

Department of Orthopedics and Surgery of the Hand, Catholic University "Sacro Cuore"

Rome, Italy

Location

Unit of Angiology, Hospital of Venice

Venice, Italy

Location

Related Publications (1)

• Camporese G, Bernardi E, Noventa F, Bosco M, Monteleone G, Santoro L, Bortoluzzi C, Freguja S, Nardin M, Marullo M, Zanon G, Mazzola C, Damiani G, Maniscalco P, Imberti D, Lodigiani C, Becattini C, Tonello C, Agnelli G; ERIKA Study Group. Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA). A phase II, multicentre, double-blind, placebo-controlled randomised study. Thromb Haemost. 2016 Aug 1;116(2):349-55. doi: 10.1160/TH16-02-0118. Epub 2016 Apr 14.

  PMID: 27075710 RESULT

MeSH Terms

Conditions

Venous Thromboembolism; Hemorrhage

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Use of placebo instead of active comparator. Small sample size and quite high exclusion rate. Local events adjudication.

Results Point of Contact

• Title: Dr. Giuseppe Camporese
• Organization: University of Padua

giuseppe.camporese@aopd.veneto.it

049 8212882

Study Officials

• Giuseppe Camporese, MD

  Unit of Angiology, University Hospital of Padua, Italy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, Coordinator of Emergency Section at the Unit of Angiology, University Hospital of Padua

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: June 27, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9)