Venous ThromboembolismPhase 2ERIKANCT01629381
Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy
A Phase 2 study testing Rivaroxaban in people with Venous Thromboembolism and Haemorrhage, run by University of Padova at 9 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Haemorrhage
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 9 sitesItaly
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova
Genova
Department of Internal Medicine, University Hospital of Napoli
Naples
Department of Orthopaedics and Traumatology, University Hospital of Pavia
Pavia
Section of Internal and Cardiovascular Medicine, Department of Internal Medicine, University of Perugia
Perugia, 06123
Department of Internal Medicine, Hospital of Piacenza
Piacenza
Unit of Angiology, Department of Internal Medicine, Azienda Ospedaliera - IRCCS
Reggio Emilia, 42100
Department of Orthopedics and Surgery of the Hand, Catholic University "Sacro Cuore"
Rome
Thrombosis Center & Knee Arthroscopy and Sports Medicine Center, Humanitas Clinical Insitute
Rozzano, Milano, 20089
Unit of Angiology, Hospital of Venice
Venice
About this study
Official title: Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)
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.
Read more
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
Read the 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%).
- Conditions
- Venous Thromboembolism, Haemorrhage
- Being tested
- Rivaroxaban, placebo
- Keywords
- knee arthroscopy, venous thromboembolism, prevention
- Medical subject headings
- Venous Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
10 mg os once daily for 1 week
placeboDrug
10 mg os once daily for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Oral Rivaroxaban 10 mg od for 7 days Receives: Drug: Rivaroxaban |
| Placebo | Placebo comparator | oral placebo od for 7 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality
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.
Measured: 3-month period
Major Bleedings
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.
Measured: 3 months
Secondary outcomes (2)
Combined Incidence of All DVT Plus Symptomatic PE
As described for the assessment of the primary efficacy outcomes
Measured: 3 months
Overall Incidence of Bleeding
As described for the primary safety outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Camporese, University of Padova
- Investigators
- Giuseppe Camporese, MD, Study chair, Unit of Angiology, University Hospital of Padua, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629381
- Sponsor's protocol ID
- 2010-024338-43
- Acronym
- ERIKA
- Status last verified
- Apr 2021
- First submitted
- 9 May 2011
- Last updated
- 21 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Camporese G, Bernardi E, Noventa F, Bosco M, Monteleone G, Santoro L, Bortoluzzi C, Freguja S, Nardin M, Marullo M, Zanon G, Mazzola C, Damiani G, Maniscalco P, Imberti D, Lodigiani C, Becattini C, Tonello C, Agnelli G; ERIKA Study Group. Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA). A phase II, multicentre, double-blind, placebo-controlled randomised study. Thromb Haemost. 2016 Aug 1;116(2):349-55. doi: 10.1160/TH16-02-0118. Epub 2016 Apr 14.
PubMed 27075710
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)
- ClinicalTrials.gov ID
- NCT01629381
- Acronym / sponsor ID
- ERIKA / 2010-024338-43
- Conditions
- Venous Thromboembolism, Haemorrhage
- Keywords
- knee arthroscopy, venous thromboembolism, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanOral Rivaroxaban 10 mg od for 7 days |
| Placebo | Placebo comparator | Drug: placebooral placebo od for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: Xarelto10 mg os once daily for 1 week | Drug | Rivaroxaban |
| placebo10 mg os once daily for 1 week | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Combined Incidence of All DVT Plus Symptomatic PE
Time frame: 3 months
Overall Incidence of Bleeding
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27075710Camporese G, Bernardi E, Noventa F, Bosco M, Monteleone G, Santoro L, Bortoluzzi C, Freguja S, Nardin M, Marullo M, Zanon G, Mazzola C, Damiani G, Maniscalco P, Imberti D, Lodigiani C, Becattini C, Tonello C, Agnelli G; ERIKA Study Group. Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA). A phase II, multicentre, double-blind, placebo-controlled randomised study. Thromb Haemost. 2016 Aug 1;116(2):349-55. doi: 10.1160/TH16-02-0118. Epub 2016 Apr 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Camporese, MD study chair
Unit of Angiology, University Hospital of Padua, Italy
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rivaroxaban in people with Venous Thromboembolism and Haemorrhage, run by University of Padova at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (time frame: 3-month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.