Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy (ERIKA)
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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) |
- 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
| Estimated Enrollment: | 500 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rivaroxaban |
Drug: Rivaroxaban
10 mg os once daily for 1 week
Other Name: Xarelto
|
| Placebo Comparator: Placebo |
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 |
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)
Contacts and Locations| Contact: Giuseppe Camporese, MD | +393479747221 | giuseppe.camporese@sanita.padova.it |
| Contact: Franco Noventa, MD | +393358768685 | franco.noventa@unipd.it |
| Italy | |
| 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 | |
| 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 | |
| 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: | June 27, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Padua:
|
knee arthroscopy venous thromboembolism prevention |
Additional relevant MeSH terms:
|
Hemorrhage Thromboembolism Venous Thromboembolism Venous Thrombosis Pathologic Processes |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 16, 2013