A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)
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|ClinicalTrials.gov Identifier: NCT02584660|
Recruitment Status : Completed
First Posted : October 22, 2015
Results First Posted : April 20, 2018
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Drug: Rivaroxaban Drug: Standard-of-care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department|
|Actual Study Start Date :||October 15, 2015|
|Actual Primary Completion Date :||March 22, 2017|
|Actual Study Completion Date :||March 22, 2017|
Participants will receive Rivaroxaban 15 milligram (mg) orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food, for approximately 69 days for a total treatment duration of 90 days.
Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.
Experimental: local Standard-of-care
Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Standard-of-care as per local protocol and defined by the medical team caring for the participant.
- Mean Duration of Hospitalization [ Time Frame: Up to Day 30 ]Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.
- Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death [ Time Frame: Up to 7, 14, 30, and 90 Days ]Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.
- Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding [ Time Frame: Up to 7, 14, 30 and 90 Days ]Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
- Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason [ Time Frame: Up to 30 and 90 Days ]Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
- Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) [ Time Frame: Day 90 ]ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.
- Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire [ Time Frame: Day 7 ]The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.
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): NCT02584660
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|