Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy (ERIKA)
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
|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)|
- 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.
- Combined incidence of all DVT plus symptomatic PE [ Time Frame: 3 months ] [ Designated as safety issue: No ]As descripted for the assessment of the primary efficay outcomes
- Overall incidence of bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]As descripted for the primary safety outcome
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
10 mg os once daily for 1 week
Other Name: Xarelto
|Placebo Comparator: Placebo||
10 mg os once daily for 1 week
Other Name: placebo
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%).
|Contact: Giuseppe Camporese, MDemail@example.com|
|Contact: Franco Noventa, MDfirstname.lastname@example.org|
|Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova||Recruiting|
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|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|
|Department of Orthopedics and Surgery of the Hand, Catholic University "Sacro Cuore"||Recruiting|
|Contact: Mario Bosco, PhD, MD +393473312952 email@example.com|
|Unit of Angiology, Hospital of Venice||Recruiting|
|Contact: Cristiano Bortoluzzi, MD +393478163641 firstname.lastname@example.org|
|Sub-Investigator: Roberto Parisi, MD|
|Principal Investigator: Cristiano Bortoluzzi, MD|
|Study Chair:||Giuseppe Camporese, MD||Unit of Angiology, University Hospital of Padua, Italy|