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NCT Number: NCT01629381

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Haemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

The treatments will be administered postoperatively (1st dose 8-10 hours after procedure), for prevention of venous thromboembolism after KA.

A bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU was due if the patients developed symptoms or signs suggestive of venous thromboembolism earlier.

Statistical & Analytical Plan and Methodology: In the absence of prophylaxis the incidence of venous thromboembolism (primary efficacy end-point) after KA, as assessed by CCDU, is about 8.0% (combining weighted results of various paper). Prophylaxis with low-molecular weight heparins assures approximately a 60-70% relative risk reduction in this setting. Based on the findings of published trials investigating the efficacy of Rivaroxaban for prevention of venous thromboembolism after elective hip and knee surgery, when using a low-molecular-weight heparin as comparator, investigators can speculate that Rivaroxaban will further reduce this incidence (at least 1.2%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Rivaroxaban

Drug

10 mg os once daily for 1 week

Other names: Xarelto

Placebo

Drug

10 mg os once daily for 1 week

Primary outcomes

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

    Time frame: 3-month period

    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.

  2. Major Bleedings

    Time frame: 3 months

    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.

Secondary outcomes

  1. Combined Incidence of All DVT Plus Symptomatic PE

    Time frame: 3 months

    As described for the assessment of the primary efficacy outcomes

  2. Overall Incidence of Bleeding

    Time frame: 3 months

    As described for the primary safety outcome

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)

Acronym: ERIKA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2012
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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