NCT02584660: MERCURY PE

A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

Completed Phase 4 Results posted Last updated 1 June 2018

What this trial tests

Phase 4 trial testing Rivaroxaban in Pulmonary Embolism in 114 participants. Completed in 22 March 2017.

Timeline

15 October 2015

Primary endpoint
22 March 2017

22 March 2017

Quick facts

Lead sponsor	Janssen Scientific Affairs, LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	15 October 2015
Primary completion	22 March 2017
Estimated completion	22 March 2017
Sites	50 locations across United States

Drugs / interventions tested

• Rivaroxaban (rivaroxaban) — full drug profile →
• Standard-of-care — full drug profile →

Conditions studied

• Pulmonary Embolism — all drugs for Pulmonary Embolism →

Sponsor

Janssen Scientific Affairs, LLC — full company profile →

Who can join

18 and older, any sex, with Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Duration of Hospitalization Primary · 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.

Group	Value	95% CI
Rivaroxaban	0.191	± 0.6862
Standard-of-care	1.393	± 1.9642

Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death Secondary · 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.

Up to 7 Days

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	0

Up to 14 Days

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	0

Up to 30 Days

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	0

Up to 90 Days

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	0

Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding Secondary · 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.

Up to 7 Days

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	0

Up to 14 Days

Group	Value	95% CI
Rivaroxaban	2
Standard-of-care	0

Up to 30 Days

Group	Value	95% CI
Rivaroxaban	3.9
Standard-of-care	1.6

Up to 90 Days

Group	Value	95% CI
Rivaroxaban	3.9
Standard-of-care	6.3

Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason Secondary · 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.

Within 30 Days

Group	Value	95% CI
Rivaroxaban	0.679	± 2.0894
Standard-of-care	1.513	± 1.9952

Within 90 Days

Group	Value	95% CI
Rivaroxaban	0.764	± 2.1829
Standard-of-care	1.812	± 2.714

Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Secondary · 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)

Item 1: Not at all

Group	Value	95% CI
Rivaroxaban	51.1
Standard-of-care	61.8

Item 1: A little

Group	Value	95% CI
Rivaroxaban	40
Standard-of-care	21.8

Item 1: Moderately

Group	Value	95% CI
Rivaroxaban	6.7
Standard-of-care	10.9

Item 1: Quite a bit

Group	Value	95% CI
Rivaroxaban	2.2
Standard-of-care	1.8

Item 1: Extremely

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	3.6

Item 2: Not at all

Group	Value	95% CI
Rivaroxaban	77.8
Standard-of-care	70.9

Item 2: A little

Group	Value	95% CI
Rivaroxaban	13.3
Standard-of-care	20

Item 2: Moderately

Group	Value	95% CI
Rivaroxaban	6.7
Standard-of-care	7.3

Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Secondary · 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

Satisfaction level: Very Satisfied

Group	Value	95% CI
Rivaroxaban	60.4
Standard-of-care	62.7

Satisfaction level: Quite Satisfied

Group	Value	95% CI
Rivaroxaban	33.3
Standard-of-care	23.7

Satisfaction level: Neither

Group	Value	95% CI
Rivaroxaban	4.2
Standard-of-care	6.8

Satisfaction level: Quite Dissatisfied

Group	Value	95% CI
Rivaroxaban	2.1
Standard-of-care	5.1

Satisfaction level: Very Dissatisfied

Group	Value	95% CI
Rivaroxaban	0
Standard-of-care	1.7

Location of care: Very Satisfied

Group	Value	95% CI
Rivaroxaban	62.5
Standard-of-care	59.3

Location of care: Quite Satisfied

Group	Value	95% CI
Rivaroxaban	33.3
Standard-of-care	30.5

Location of care: Neither

Group	Value	95% CI
Rivaroxaban	4.2
Standard-of-care	6.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 2.5 years. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rivaroxaban

Serious: 5/49 (10%)

Deaths: 0/49

Standard-of-care

Serious: 7/63 (11%)

Deaths: 0/63

Serious adverse events (14 terms)

Reaction	System	Rivaroxaban	Standard-of-care
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Atrial Fibrillation	Cardiac disorders	—	—
Chest Pain	General disorders	—	—
Pain	General disorders	—	—
Systemic Inflammatory Response Syndrome	General disorders	—	—
Device Related Infection	Infections and infestations	—	—
Embolic Pneumonia	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	—	—
May-Thurner Syndrome	Vascular disorders	—	—
Thrombosis	Vascular disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Rivaroxaban	Standard-of-care
Chest Pain	General disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Menorrhagia	Reproductive system and breast disorders	—	—
Non-Cardiac Chest Pain	General disorders	—	—
Sinusitis	Infections and infestations	—	—
Head Injury	Injury, poisoning and procedural complications	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Muscle Spasms	Musculoskeletal and connective tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Dyspnoea, Atrial Fibrillation, Chest Pain, Pain, Systemic Inflammatory Response Syndrome, Device Related Infection, Embolic Pneumonia, Influenza.

Data from ClinicalTrials.gov NCT02584660 adverse events section.

Sponsor's own description

The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance.
   Kline JA, Kahler ZP, Beam DM. · · 2016 · cited 49× · PMID 27143861 · DOI 10.2147/ppa.s104446
2. Emergency Department Discharge of Pulmonary Embolus Patients.
   Frank Peacock W, Coleman CI, Diercks DB, Francis S, et al · · 2018 · cited 38× · PMID 29757489 · DOI 10.1111/acem.13451
3. Pulmonary Embolism: Contemporary Medical Management and Future Perspectives.
   Barco S, Konstantinides SV. · · 2018 · cited 2× · PMID 30402174 · DOI 10.3400/avd.ra.18-00054