A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
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|ClinicalTrials.gov Identifier: NCT02555878|
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Rivaroxaban Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||841 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism|
|Actual Study Start Date :||September 11, 2015|
|Estimated Primary Completion Date :||July 13, 2018|
|Estimated Study Completion Date :||August 30, 2018|
Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
Participants will be administered matching placebo tablet orally once daily for 180 days.
Placebo tablet will be administered orally once daily for 180 days.
- Time From Randomization to First Occurrence of Objectively Confirmed Symptomatic and Asymptomatic Lower Extremity Proximal DVT,Symptomatic Lower Extremity Distal DVT,Symptomatic Upper Extremity DVT,Symptomatic Non-Fatal PE,Incidental PE,VTE-Related Death [ Time Frame: From Randomization to the Day 180 visit as Adjudicated by an Independent blinded CEC ]Diagnosis of DVT confirmed by compression ultrasonography and diagnosis of PE through computerized tomography or ventilation/perfusion lung scan.
- The Primary Safety Endpoint is the Major Bleeding Events as Defined by ISTH [ Time Frame: From the Time of Randomization to 2 Days After the Last Dose of Study Drug ]
Major bleeding is defined as clinically overt bleeding that is associated with:
A reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or A transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or death.
- The Key Secondary Efficacy Endpoints Include the Following: 1) Symptomatic VTE Events (DVT/PE) and VTE-Related Deaths and 2) All-cause Mortality [ Time Frame: From the time of randomization to the Day 180 visit ]
- Secondary Safety Endpoints Include the Proportion of Clinically Relevant Non-Major Bleeding, Minor Bleeding, any Bleeding (Defined as Major, Clinically Relevant Non-Major, and Minor Bleeding as defined by ISTH) [ Time Frame: From the Time of Randomization to Two Days After the Last Dose of Study Drug ]According to International Society on Thrombosis & Haemostasis (ISTH) definition.
- Number of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (30 days after last dose administration) ]Adverse events or serious adverse events will be collected and entered into the eCRF. All SAEs that are not outcome events occurring during the study must be reported to the appropriate sponsor contact person by study-site personnel within 24 hours of their knowledge of the event.
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): NCT02555878
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|