Trial Outcomes & Findings for Safety of Intravenous Thrombolytics in Stroke on Awakening (NCT NCT01643902)

Last Updated: 2017-04-17

Results Overview

Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison. ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline. NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

within 36 hours of treatment

Results posted on

2017-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	IV tPA Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Intravenous Thrombolytics in Stroke on Awakening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV tPA n=20 Participants Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: within 36 hours of treatment

Population: No symptomatic intracerebral hemorrhage was observed by either NINDS IV tPA trial or ECASS 3 criteria.

Outcome measures

Outcome measures
Measure	IV Rt-PA n=20 Participants Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival.
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment	0 participants

SECONDARY outcome

Timeframe: 90 days

The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6. 0, no symptoms at all. 1. no significant disability despite symptoms; able to carry out all usual duties and activities. 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3. moderate disability; requiring some help, but able to walk without assistance. 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6. dead.

Outcome measures

Outcome measures
Measure	IV Rt-PA n=20 Participants Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival.
Functional Outcome by the Modified Rankin Scale at 90 Days	1 units on a scale Interval 0.0 to 5.0

Adverse Events

IV tPA

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IV tPA n=20 participants at risk Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
Nervous system disorders Asymptomatic intracerebral hemorrhage	10.0% 2/20 • Number of events 2

Additional Information

Victor C. Urrutia

Johns Hopkins University School of Medicine

Phone: 410-955-2228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place