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Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

NCT01629381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-05-21

Study results available
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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 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

Conditions

  • Venous Thromboembolism
  • Haemorrhage

Interventions

DRUG

Rivaroxaban

10 mg os once daily for 1 week

DRUG

placebo

10 mg os once daily for 1 week

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Giuseppe Camporese, MD · Unit of Angiology, University Hospital of Padua, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629381 on ClinicalTrials.gov