NCT02039375: OPTIMIST

Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Completed NA Results posted Last updated 23 March 2020

What this trial tests

NA trial testing "Hopkins" post tPA for ischemic stroke monitoring protocol in Stroke in 35 participants. Completed in 30 June 2018.

Timeline

1 March 2014

Primary endpoint
21 March 2018

30 June 2018

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	35
Start date	1 March 2014
Primary completion	21 March 2018
Estimated completion	30 June 2018
Sites	1 location across United States

Drugs / interventions tested

• "Hopkins" post tPA for ischemic stroke monitoring protocol

Conditions studied

• Stroke — all drugs for Stroke →
• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 80, any sex, with Stroke or Ischemic Stroke. 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.

Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration Primary · 24 hours

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	0

Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS) Secondary · 24 hours

The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	1	0 – 3

Degree of Disability as Assessed by the Modified Rankin Score (mRS) Secondary · At the time of discharge from the hospital, up to 90 days

The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal. 1. \- some symptoms, able to do all prior activities, does not need help from others. 2. \- some symptoms, unable to do all prior activities, does not need help from others. 3. \- needs help from others, able to walk. 4. \- needs help from other, unable to walk without help. 5. \- needs total care. 6. \- the patient has expired.

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	1	0 – 3

Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS Secondary · At 90 days

The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	0	0 – 1

Degree of Disability at 90 Days as Assessed by the mRS Secondary · At 90 days

The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal. 1. some symptoms, able to do all prior activities, does not need help from others. 2. some symptoms, unable to do all prior activities, does not need help from others. 3. needs help from others, able to walk. 4. needs help from other, unable to walk without help. 5. needs total care. 6. the patient has expired.

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	0	0 – 6

Mortality at 90 Days Secondary · 90 days

Group	Value	95% CI
"Hopkins" Post tPA Monitoring Protocol	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

"Hopkins" Post tPA Monitoring Protocol

Serious: 1/35 (3%)

Deaths: 1/35

Serious adverse events (1 terms)

Reaction	System	"Hopkins" Post tPA Monitor…
Mortality	Cardiac disorders	—

Most-reported serious reactions: Mortality.

Data from ClinicalTrials.gov NCT02039375 adverse events section.

Sponsor's own description

Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5 hours of symptom onset. It is current practice that post-tPA patients are monitored in an intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part due to frequent vital sign and neurological monitoring that is currently the standard of care. However, rigorous evidence to support this practice is largely lacking. In a retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHBMC), investigators have shown that most patients who have ICU needs in the first 24 hours after tPA administration develop such needs by the end of the tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not require further ICU resources if patients' presenting NIH Stroke Scale (NIHSS) is below 10. This study is a prospective clinical trial that aims at establishing the first proof-of-concept and feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a non-ICU environment may improve cost-effective utilization of ICU resources and reduce the length of hospitalization for stroke patients.

Publications & conference data

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

1. Safety Trial of Low-Intensity Monitoring After Thrombolysis: Optimal Post Tpa-Iv Monitoring in Ischemic STroke (OPTIMIST).
   Faigle R, Butler J, Carhuapoma JR, Johnson B, et al · · 2020 · cited 30× · PMID 31839859 · DOI 10.1177/1941874419845229
2. Low-Intensity Monitoring After Stroke Thrombolysis During the COVID-19 Pandemic.
   Faigle R, Johnson B, Summers D, Khatri P, et al · · 2020 · cited 7× · PMID 32514708 · DOI 10.1007/s12028-020-00998-0