StrokePhase 3EMPATHY-INCT04153942
Earlier Mobilization Post Acute Thrombolysis
A Phase 3 study testing Mobilization in people with Stroke and Stroke, Acute, run by Brian Silver.
Trial summary
This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Mobilization
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age 18 years or older
- Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
- Patient and/or Legally Authorized Representative provide consent
Who cannot join
- Venous thromboembolism present at symptom onset
- Pneumonia present at symptom onset
- STEMI at symptom onset
- Positive troponins at symptom onset according to local values
- Bone fracture at symptom onset
- Treatment includes or anticipated to include thrombectomy
Show all 15Show fewer
- Intubation anticipated or occurred
- Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
- Pre-screening systolic blood pressure < 110 mmHg
- Resting pulse oximetry < 92% (with or without supplemental oxygen)
- Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
- Baseline modified Rankin Scale score > 2
- Known pregnancy
- Patient not anticipated to survive 3 months
- Patient not anticipated to follow-up at 3 months
About this study
This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Being tested
- Mobilization
- Keywords
- Mobilization, Thrombolysis, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery
- Medical subject headings
- Stroke, Ischemic Stroke, Ischemia, Cerebrovascular Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationBehavioural
Any movement out of bed
| Study group | Role | What they receive |
|---|---|---|
| 12-Hour Bed Rest | Experimental | Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care Receives: Behavioral: Mobilization |
| 24-Hour Bed Rest | Active comparator | Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care Receives: Behavioral: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day mRS
Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days
Measured: 90 days post bed rest
Secondary outcomes (5)
Pneumonia
Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
Measured: Duration of hospitalization stay, average 5 days
Venous Thromboembolism
Determine whether rates of VTE are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
Measured: Duration of hospitalization stay, average 5 days
Neurological Worsening
Determine whether rates of neurological worsening are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
Measured: Duration of hospitalization stay, average 5 days
Readmission
Determine whether rates of readmission are at least similar in the two arms.
Measured: 90 days post bed rest
Length of Stay
Determine whether hospital length of stay are at least similar in the two arms. This will ve measured in days.
Measured: Duration of hospitalization stay, average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study startAug 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Study never started/initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Silver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Silver, University of Massachusetts, Worcester
- Investigators
- Brian Silver, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153942
- Sponsor's protocol ID
- H00018238
- Acronym
- EMPATHY-I
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earlier Mobilization Post Acute Thrombolysis
- ClinicalTrials.gov ID
- NCT04153942
- Acronym / sponsor ID
- EMPATHY-I / H00018238
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Keywords
- Mobilization, Thrombolysis, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started/initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brian SilverUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-Hour Bed Rest | Experimental | Behavioral: MobilizationSubjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care |
| 24-Hour Bed Rest | Active comparator | Behavioral: MobilizationSubjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
- Patient and/or Legally Authorized Representative provide consent
Key exclusion criteria (15 listed)
- Venous thromboembolism present at symptom onset
- Pneumonia present at symptom onset
- STEMI at symptom onset
- Positive troponins at symptom onset according to local values
- Bone fracture at symptom onset
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 |
|---|---|---|
| MobilizationAny movement out of bed | Behavioural | 12-Hour Bed Rest, 24-Hour Bed Rest |
Primary outcome
90 day mRS
Time frame: 90 days post bed rest
Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days
5 secondary outcomes
Pneumonia
Time frame: Duration of hospitalization stay, average 5 days
Venous Thromboembolism
Time frame: Duration of hospitalization stay, average 5 days
Neurological Worsening
Time frame: Duration of hospitalization stay, average 5 days
Readmission
Time frame: 90 days post bed rest
Length of Stay
Time frame: Duration of hospitalization stay, average 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Brian Silver, MD principal investigator
UMass Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mobilization in people with Stroke and Stroke, Acute, run by Brian Silver.
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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
90 day mRS (time frame: 90 days post bed rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.