Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy (ERIKA)
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|ClinicalTrials.gov Identifier: NCT01629381|
Recruitment Status : Unknown
Verified July 2013 by Giuseppe Camporese, University of Padua.
Recruitment status was: Recruiting
First Posted : June 27, 2012
Last Update Posted : July 4, 2013
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 or disease||Intervention/treatment||Phase|
|Venous Thromboembolism Haemorrhage||Drug: Rivaroxaban Drug: placebo||Phase 2|
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%).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||March 2014|
Oral Rivaroxaban 10 mg od for 7 days
10 mg os once daily for 1 week
Other Name: Xarelto
Placebo Comparator: Placebo
oral placebo od for 7 days
10 mg os once daily for 1 week
- 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.
- 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.
- Combined incidence of all DVT plus symptomatic PE [ Time Frame: 3 months ]As described for the assessment of the primary efficacy outcomes
- Overall incidence of bleeding [ Time Frame: 3 months ]As described for the primary safety outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629381
|Contact: Giuseppe Camporese, MDfirstname.lastname@example.org|
|Contact: Franco Noventa, MDemail@example.com|
|Thrombosis Center & Knee Arthroscopy and Sports Medicine Center, Humanitas Clinical Insitute||Recruiting|
|Rozzano, Milano, Italy, 20089|
|Contact: Corrado Lodigiani, MD +39335265699 firstname.lastname@example.org|
|Principal Investigator: Corrado Lodigiani, MD|
|Sub-Investigator: Corrado Bait, MD|
|Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova||Recruiting|
|Contact: Claudio Mazzola, MD +393472321691 email@example.com|
|Principal Investigator: Claudio Mazzola, MD|
|Department of Internal Medicine, University Hospital of Napoli||Recruiting|
|Contact: Pierpaolo Di Micco, MD +393398078146 firstname.lastname@example.org,|
|Contact: Paolo Dimaro, MD email@example.com|
|Principal Investigator: Pierpaolo Di Micco, MD|
|Department of Orthopaedics and Traumatology, University Hospital of Pavia||Recruiting|
|Contact: Giacomo Zanon, MD firstname.lastname@example.org|
|Contact: Matteo Marullo, MD email@example.com|
|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 firstname.lastname@example.org|
|Contact: Maria Cristina Vedovati, MD +393288518290 email@example.com|
|Sub-Investigator: Cecilia Becattni, MD|
|Department of Internal Medicine, Hospital of Piacenza||Recruiting|
|Contact: Davide Imberti, MD +393384547502 firstname.lastname@example.org|
|Unit of Angiology, Department of Internal Medicine, Azienda Ospedaliera - IRCCS||Recruiting|
|Reggio Emilia, Italy, 42100|
|Contact: Angelo Ghirarduzzi, MD +393391241681 email@example.com|
|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|
|Contact: Mario Bosco, PhD, MD +393473312952 firstname.lastname@example.org|
|Unit of Angiology, Hospital of Venice||Recruiting|
|Contact: Cristiano Bortoluzzi, MD +393478163641 email@example.com|
|Sub-Investigator: Roberto Parisi, MD|
|Principal Investigator: Cristiano Bortoluzzi, MD|
|Study Chair:||Giuseppe Camporese, MD||Unit of Angiology, University Hospital of Padua, Italy|