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Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy (ERIKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Padua
Sponsor:
Information provided by (Responsible Party):
Giuseppe Camporese, University of Padua
ClinicalTrials.gov Identifier:
NCT01629381
First received: May 9, 2011
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Venous Thromboembolism
Haemorrhage
Drug: Rivaroxaban
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)

Resource links provided by NLM:


Further study details as provided by University of Padua:

Primary Outcome Measures:
  • Incidence of symptomatic venous thromboembolism plus asymptomatic proximal vein thrombosis and all-cause mortality [ Time Frame: 3-month period ] [ Designated as safety issue: No ]
    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.

  • Major bleedings [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Combined incidence of all DVT plus symptomatic PE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As described for the assessment of the primary efficacy outcomes

  • Overall incidence of bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    As described for the primary safety outcome


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Oral Rivaroxaban 10 mg od for 7 days
Drug: Rivaroxaban
10 mg os once daily for 1 week
Other Name: Xarelto
Placebo Comparator: Placebo
oral placebo od for 7 days
Drug: placebo
10 mg os once daily for 1 week
Other Name: placebo

Detailed Description:

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%).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Diagnostic arthroscopy
  2. Patients concomitantly treated systemically with strong concurrent CYP3A4 and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors.
  3. Hypersensitivity to the active substance or to any of the excipients of study drug
  4. Pregnant women or breast-feeding.
  5. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
  6. Known thrombophilia (hereditary or acquired)
  7. Mandatory anticoagulation.
  8. Known severe bleeding tendency
  9. Clinically significant active bleeding.
  10. Severe renal failure (GFR<30mL/min/1.73m2)
  11. Patients participating in another clinical trial.
  12. Recent mayor surgery (6 to 12 weeks)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629381

Contacts
Contact: Giuseppe Camporese, MD +393479747221 giuseppe.camporese@sanita.padova.it
Contact: Franco Noventa, MD +393358768685 franco.noventa@unipd.it

Locations
Italy
Thrombosis Center & Knee Arthroscopy and Sports Medicine Center, Humanitas Clinical Insitute Recruiting
Rozzano, Milano, Italy, 20089
Contact: Corrado Lodigiani, MD    +39335265699    corrado.lodigiani@humanitas.it   
Principal Investigator: Corrado Lodigiani, MD         
Sub-Investigator: Corrado Bait, MD         
Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova Recruiting
Genova, Italy
Contact: Claudio Mazzola, MD    +393472321691    claudio.mazzola@galliera.it   
Principal Investigator: Claudio Mazzola, MD         
Department of Internal Medicine, University Hospital of Napoli Recruiting
Napoli, Italy
Contact: Pierpaolo Di Micco, MD    +393398078146    pdimicco@libero.it,   
Contact: Paolo Dimaro, MD       paolo.dimaro@fastwebnet.it   
Principal Investigator: Pierpaolo Di Micco, MD         
Department of Orthopaedics and Traumatology, University Hospital of Pavia Recruiting
Pavia, Italy
Contact: Giacomo Zanon, MD       zanon.g@libero.it   
Contact: Matteo Marullo, MD       matteomarullo@hotmail.it   
Principal Investigator: Giacomo Zanon, MD         
Sub-Investigator: Matteo Marullo, MD         
Section of Internal and Cardiovascular Medicine, Department of Internal Medicine, University of Perugia Recruiting
Perugia, Italy, 06123
Contact: Cecilia Becattini, MD    +393478752203    cecilia.becattini@unipg.it   
Contact: Maria Cristina Vedovati, MD    +393288518290    mcristinaved@yahoo.it   
Sub-Investigator: Cecilia Becattni, MD         
Department of Internal Medicine, Hospital of Piacenza Recruiting
Piacenza, Italy
Contact: Davide Imberti, MD    +393384547502    d.imberti@ausl.pc.it   
Unit of Angiology, Department of Internal Medicine, Azienda Ospedaliera - IRCCS Recruiting
Reggio Emilia, Italy, 42100
Contact: Angelo Ghirarduzzi, MD    +393391241681    ghirarduzzi.angelo@asmn.re.it   
Contact: Maria Rosaria Veropalumbo, MD    +3289139222    MariaRosaria.Veropalumbo@asmn.re.it   
Principal Investigator: Angelo Ghirarduzzi, MD         
Sub-Investigator: Maria Rosaria Veropalumbo, MD         
Department of Orthopedics and Surgery of the Hand, Catholic University "Sacro Cuore" Recruiting
Rome, Italy
Contact: Mario Bosco, PhD, MD    +393473312952    mbosco@rm.unicatt.it   
Unit of Angiology, Hospital of Venice Recruiting
Venice, Italy
Contact: Cristiano Bortoluzzi, MD    +393478163641    crisbort@libero.it   
Sub-Investigator: Roberto Parisi, MD         
Principal Investigator: Cristiano Bortoluzzi, MD         
Sponsors and Collaborators
University of Padua
Investigators
Study Chair: Giuseppe Camporese, MD Unit of Angiology, University Hospital of Padua, Italy
  More Information

No publications provided

Responsible Party: Giuseppe Camporese, MD, Principal Investigator, Coordinator of Emergency Section at the Unit of Angiology, University Hospital of Padua, University of Padua
ClinicalTrials.gov Identifier: NCT01629381     History of Changes
Other Study ID Numbers: 2010-024338-43
Study First Received: May 9, 2011
Last Updated: July 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padua:
knee arthroscopy
venous thromboembolism
prevention

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Hemorrhage
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Pathologic Processes
Thrombosis
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014