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CompletedNCT03785678TIMELESSUpdated May 22, 2024Results posted

Tenecteplase in Stroke Patients Between 4.5 and 24 Hours

A Phase 3 interventional study of Tenecteplase and Placebo in THROMBOLYSIS, sponsored by Genentech, Inc.. Completed at 97 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Genentech, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
458
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS).

All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90.

02

Conditions studied

  • THROMBOLYSIS
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient/legally authorized representative has signed the Informed Consent Form
  • Age >= 18 years
  • AIS symptom onset within 4.5 to 24 hours Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the ICA, M1, or M2 vessels
  • Functionally independent (mRS 0-2) prior to stroke onset
  • Baseline NIHSS >=5 and that remains >=5 immediately prior to randomization
  • Neuroimaging: ICA or M1, M2 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) AND target mismatch profile on CT perfusion or MR perfusion (ischemic core volume \<70 mL, mismatch ratio is >=1.8 and mismatch volume is >= 15 mL)
  • The mismatch volume is determined by FDA-approved imaging software in real time based on the difference between the ischemic core lesion volume and the Tmax>6s lesion volume. If both a CT perfusion and a multimodal MRI scan are performed prior to enrollment, the later of the 2 scans is assessed to determine eligibility. Only an intracranial MRA is required for patients screened with MRA; cervical MRA is not required. Cervical and intracranial CTA are typically obtained simultaneously in patients screened with CTA, but only the intracranial CTA is required for enrollment.

Alternative neuroimaging:

  • If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or M1, M2 occlusion AND target mismatch profile (ischemic core volume \<70 mL, mismatch ratio >= 1.8 and mismatch volume >= 15 mL as determined by RAPID software)
  • If magnetic resonance perfusion (MRP) is technically inadequate: ICA or M1, M2 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND diffusion-weighted imaging (DWI) lesion volume \<=25 mL for an M1 or ICA occlusion and =\<15 mL for an M2 occlusion
  • If CTP is technically inadequate: patient can be screened with MRI and randomized if neuroimaging criteria are met.
  • Ability to comply with the study protocol, in the investigator's judgment

Exclusion criteria

Exclusion Criteria:

General

  • Current participation in another investigational drug or device study
  • Active internal bleeding
  • Known hypersensitivity or allergy to any ingredients of tenecteplase
  • Known bleeding diathesis
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR >1.7
  • Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
  • Pregnant
  • Intracranial neoplasm (except small meningioma), arteriovenous malformation, or aneurysm
  • Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
  • Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg)
  • For participants with suspected coagulopathy, platelet count must be checked prior to randomization and participant is excluded if baseline platelet count \<100,000/microL
  • Baseline blood glucose >400 mg/dL (22.20 mmol/L)
  • Baseline blood glucose \<50 mg/dL needs to be normalized prior to randomization
  • Clot retrieval attempted using a neurothrombectomy device prior to randomization
  • Intracranial or intraspinal surgery or trauma within 2 months
  • Treatment with a thrombolytic within the last 3 months prior to randomization
  • Other serious, advanced, or terminal illness (investigator judgment) with life expectancy less than 6 months
  • Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations
  • History of cerebrovascular accident in the last 90 days
  • Presumed septic embolus; suspicion of bacterial endocarditis
  • Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed

Imaging

  • Unable to undergo a contrast brain perfusion scan with either MRI or CT
  • Extensive early ischemic change (hypodensity) on non-contrast CT estimated to be >1/3 MCA territory, or significant hypodensity outside the Tmax>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria)
  • Significant mass effect
  • Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
  • Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
458 participants (actual)

Study arms

  • Experimental
    Tenecteplase

    Patients in this arm will receive Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds.

    Biological: Tenecteplase

  • Placebo comparator
    Placebo

    Patients in this arm will receive placebo administered as a single bolus injection over 5 seconds.

    Other: Placebo

Interventions

  • BiologicalTenecteplase

    The investigational medicinal product (IMP) for this study is tenecteplase. The recommended total dose for this study is weight-based with 0.25 mg of tenecteplase per kg, not exceeding a maximum dose of 25 mg. A single bolus dose should be administered over 5 seconds based on patient weight.

  • OtherPlacebo

    Placebo is being used as the comparator since a thrombolytic is only FDA-approved in the United States for use out to 3 hours, and the standard of care guidelines support use out to 4.5 hours.

06

What researchers measure

Primary outcomes

  1. Ordinal Modified Rankin Scale (mRS) Score at Day 90

    The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms 1. = No significant disability 2. = Slight disability 3. = Moderate disability 4. = Moderately severe disability 5. = Severe disability 6. = Death

    Time frame: Day 90

Secondary outcomes

  1. Proportion of Patients With Functional Independence at Day 90

    Functional independence, was defined as an mRS of 0-2 (no symptoms to mild symptoms), at Day 90.

    Time frame: Day 90

  2. Proportion of Patients With Recanalization at 24 Hours Post-randomization

    This endpoint measured complete or partial recanalization (restored blood flow) on CT angiography (CTA)/magnetic resonance angiography (MRA) post-randomization, defined as complete or partial recanalization on CT angiography (CTA)/magnetic resonance angiography (MRA).

    Time frame: Day 2

  3. Proportion of Patients With Reperfusion at 24 Hours Post-randomization

    This endpoint was defined by the proportion of participants with reperfusion (the restoration of blood flow to an organ or tissue after having been blocked) at 24 hours post-randomization, defined as \> 90% reduction in Tmax \> 6s lesion volume.

    Time frame: Day 2

  4. Proportion of Patients With Angiographic Reperfusion at Completion of Angiographic Procedure

    Angiographic reperfusion was evaluated using the modified Thrombolysis in Cerebral Infarction (TICI) Scale: 0: No perfusion or anterograde flow beyond site of occlusion. 1. Contrast passes the area of occlusion but fails to opacify the entire cerebral bed distal to the obstruction during angiographic run. 2. Partial perfusion wherein the contrast passes the occlusion and opacifies the distal arterial bed but rate of entry or clearance from the bed is slower than non-involved territories 2A: \< 50% of territory visualized 2B: ≥ 50% of territory is visualized 2C: Near complete perfusion except for slow flow in a few distal cortical vessels or presence of small distal cortical emboli 3. Complete reperfusion with normal filling.

    Time frame: Day 1

  5. Median NIHSS Score at Day 90

    The National Institutes of Health Stroke Score (NIHSS) is a 15-item scale that measures neurological deficit in acute stroke patients. Each item is ranked using a 3-, 4-, or 5-point scale, including allowances for items that cannot be scored due to the patient's condition, with higher scores indicating more severe deficit. Total scores range from 0-42, with higher scores indicating more severe deficits.

    Time frame: Day 90

  6. Proportion of Patients With a Barthel Index (BI) Score ≥ 95 at Day 90

    The Barthel Index (BI) is a 10-item ordinal scale used to measure performance in activities of daily living (ADL) and mobility. The BI scoring range is from 0-100, with lower scores representing greater dependency.

    Time frame: Day 90

  7. Proportion of Patients With Good Recovery Based on the Glasgow Outcome Scale (GOS) at Day 90

    The Glasgow Outcome Scale (GOS) is a scale used to assess recovery of participants with brain damage. The scale has 5 categories: 1. = Death 2. = Persistent vegetative state 3. = Severe disability 4. = Moderate disability 5. = Good recovery The GOS was re-scaled from observed data. For this measure, 1 = good recovery and 5 = death.

    Time frame: Day 90

  8. Incidence of Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours

    Time frame: Within 36 hours (Day 2) of treatment

  9. Mortality Rate up to Day 30 and Day 90

    Time frame: Day 30 and Day 90

  10. Proportion of Patients With Parenchymal Hematoma Type 2 (PH2) at the 72-96 Hour Visit

    Time frame: Day 3

07

Results

Posted May 22, 2024

Participant flow

Participant flow — Overall Study
MilestoneTenecteplasePlacebo
Started228230
Completed175181
Not completed5349
Withdrew: Death4442
Withdrew: Lost to follow-up42
Withdrew: Physician decision02
Withdrew: Withdrawal by subject53

Outcome measures

PrimaryOrdinal Modified Rankin Scale (mRS) Score at Day 90

The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms 1. = No significant disability 2. = Slight disability 3. = Moderate disability 4. = Moderately severe disability 5. = Severe disability 6. = Death

Time frame:
Day 90
Reported as:
Number · Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90
Count of participantsTenecteplasePlacebo
03531
13830
23136
33441
42934
51513
64444
SecondaryProportion of Patients With Functional Independence at Day 90

Functional independence, was defined as an mRS of 0-2 (no symptoms to mild symptoms), at Day 90.

Time frame:
Day 90
Reported as:
Number · Percentage of participants
Proportion of Patients With Functional Independence at Day 90
Percentage of participantsTenecteplasePlacebo
mRS ≤ 2 at Day 9046.042.4
mRS > 2 at Day 9054.057.6
SecondaryProportion of Patients With Recanalization at 24 Hours Post-randomization

This endpoint measured complete or partial recanalization (restored blood flow) on CT angiography (CTA)/magnetic resonance angiography (MRA) post-randomization, defined as complete or partial recanalization on CT angiography (CTA)/magnetic resonance angiography (MRA).

Time frame:
Day 2
Reported as:
Number · Percentage of participants
Proportion of Patients With Recanalization at 24 Hours Post-randomization
Percentage of participantsTenecteplasePlacebo
Complete recanalization76.763.9
None or partial recanalization23.336.1
SecondaryProportion of Patients With Reperfusion at 24 Hours Post-randomization

This endpoint was defined by the proportion of participants with reperfusion (the restoration of blood flow to an organ or tissue after having been blocked) at 24 hours post-randomization, defined as \> 90% reduction in Tmax \> 6s lesion volume.

Time frame:
Day 2
Reported as:
Number · Percentage of participants
Proportion of Patients With Reperfusion at 24 Hours Post-randomization
Percentage of participantsTenecteplasePlacebo
> 90% reduction in Tmax > 6s lesion volume56.957.7
≤ 90% reduction43.142.3
SecondaryProportion of Patients With Angiographic Reperfusion at Completion of Angiographic Procedure

Angiographic reperfusion was evaluated using the modified Thrombolysis in Cerebral Infarction (TICI) Scale: 0: No perfusion or anterograde flow beyond site of occlusion. 1. Contrast passes the area of occlusion but fails to opacify the entire cerebral bed distal to the obstruction during angiographic run. 2. Partial perfusion wherein the contrast passes the occlusion and opacifies the distal arterial bed but rate of entry or clearance from the bed is slower than non-involved territories 2A: \< 50% of territory visualized 2B: ≥ 50% of territory is visualized 2C: Near complete perfusion except for slow flow in a few distal cortical vessels or presence of small distal cortical emboli 3. Complete reperfusion with normal filling.

Time frame:
Day 1
Reported as:
Number · Percentage of participants
Proportion of Patients With Angiographic Reperfusion at Completion of Angiographic Procedure
Percentage of participantsTenecteplasePlacebo
Achieving TICI 2b or TICI 389.185.4
Achieving TICI < 2b10.914.6
SecondaryMedian NIHSS Score at Day 90

The National Institutes of Health Stroke Score (NIHSS) is a 15-item scale that measures neurological deficit in acute stroke patients. Each item is ranked using a 3-, 4-, or 5-point scale, including allowances for items that cannot be scored due to the patient's condition, with higher scores indicating more severe deficit. Total scores range from 0-42, with higher scores indicating more severe deficits.

Time frame:
Day 90
Reported as:
Median · Scores on a scale
Median NIHSS Score at Day 90
Scores on a scaleTenecteplasePlacebo
Median NIHSS Score at Day 901.0 (0 to 31)1.0 (0 to 26)
SecondaryProportion of Patients With a Barthel Index (BI) Score ≥ 95 at Day 90

The Barthel Index (BI) is a 10-item ordinal scale used to measure performance in activities of daily living (ADL) and mobility. The BI scoring range is from 0-100, with lower scores representing greater dependency.

Time frame:
Day 90
Reported as:
Number · Percentage of participants
Proportion of Patients With a Barthel Index (BI) Score ≥ 95 at Day 90
Percentage of participantsTenecteplasePlacebo
BI score ≥ 95 at Day 9060.558.4
BI score < 95 at Day 9039.541.6
SecondaryProportion of Patients With Good Recovery Based on the Glasgow Outcome Scale (GOS) at Day 90

The Glasgow Outcome Scale (GOS) is a scale used to assess recovery of participants with brain damage. The scale has 5 categories: 1. = Death 2. = Persistent vegetative state 3. = Severe disability 4. = Moderate disability 5. = Good recovery The GOS was re-scaled from observed data. For this measure, 1 = good recovery and 5 = death.

Time frame:
Day 90
Reported as:
Number · Percentage of participants
Proportion of Patients With Good Recovery Based on the Glasgow Outcome Scale (GOS) at Day 90
Percentage of participantsTenecteplasePlacebo
Good recovery GOS score (=1)36.530.8
GOS score > 163.569.2
SecondaryIncidence of Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
Time frame:
Within 36 hours (Day 2) of treatment
Reported as:
Number · Percentage of participants
Incidence of Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
Percentage of participantsTenecteplasePlacebo
Incidence of Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours3.22.3
SecondaryMortality Rate up to Day 30 and Day 90
Time frame:
Day 30 and Day 90
Reported as:
Number · Percentage of participants
Mortality Rate up to Day 30 and Day 90
Percentage of participantsTenecteplasePlacebo
Death within 30 days14.715.0
Death within 90 days19.718.2
SecondaryProportion of Patients With Parenchymal Hematoma Type 2 (PH2) at the 72-96 Hour Visit
Time frame:
Day 3
Reported as:
Number · Percentage of participants
Proportion of Patients With Parenchymal Hematoma Type 2 (PH2) at the 72-96 Hour Visit
Percentage of participantsTenecteplasePlacebo
Proportion of Patients With Parenchymal Hematoma Type 2 (PH2) at the 72-96 Hour Visit3.72.8

Adverse events

Collected over From treatment visit to Day 90 follow-up. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tenecteplase44/228 (19.3%)91/218 (41.7%)145/218 (66.5%)
Placebo44/230 (19.1%)102/214 (47.7%)136/214 (63.6%)
Most frequent serious events
Showing 10 of 153
Most frequent serious events
EventTenecteplasePlacebo
Stroke in evolutionNervous system disorders7/21813/214
Respiratory failureRespiratory, thoracic and mediastinal disorders8/2188/214
HypotensionVascular disorders8/2180/214
Cerebral artery occlusionNervous system disorders5/2187/214
Cerebrovascular accidentNervous system disorders6/2187/214
AnaemiaBlood and lymphatic system disorders7/2180/214
Brain oedemaNervous system disorders7/2182/214
Acute respiratory failureRespiratory, thoracic and mediastinal disorders7/2183/214
SepsisInfections and infestations5/2186/214
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/2186/214
Most frequent other events
Showing 10 of 16
Most frequent other events
EventTenecteplasePlacebo
Urinary tract infectionInfections and infestations29/21820/214
Haemorrhagic transformation strokeNervous system disorders28/21825/214
HypokalaemiaMetabolism and nutrition disorders18/21827/214
Cerebral haemorrhageNervous system disorders22/21813/214
HeadacheNervous system disorders18/21821/214
Haemorrhagic infarctionVascular disorders20/21821/214
Atrial fibrillationCardiac disorders12/21818/214
Subarachnoid haemorrhageNervous system disorders16/21817/214
HypotensionVascular disorders12/21817/214
PyrexiaGeneral disorders12/21815/214

Baseline characteristics

Age, Continuous
Age, Continuous(Years)TenecteplasePlaceboTotal
Mean70.2 ± 13.571.3 ± 13.670.8 ± 13.5
Sex: Female, Male
Sex: Female, Male(Participants)TenecteplasePlaceboTotal
Female122123245
Male106107213
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TenecteplasePlaceboTotal
Hispanic or Latino172239
Not Hispanic or Latino201197398
Unknown or Not Reported101121
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TenecteplasePlaceboTotal
American Indian or Alaska Native022
Asian11920
Native Hawaiian or Other Pacific Islander235
Black or African American313263
White169170339
More than one race000
Unknown or Not Reported151429
08

Study locations

97 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-3300, United States
  • Banner Desert Medical Center
    Mesa, Arizona 85202, United States
  • Kaiser Permanente - Anaheim (E. La Palma)
    Anaheim, California 92806, United States
  • Mills-Peninsula Medical Center
    Burlingame, California 94010, United States
  • John Muir Health, Concord Medical Center
    Concord, California 94520, United States
  • Sutter Davis Hospital
    Davis, California 95616, United States
  • Kaiser Permanente - Fontana
    Fontana, California 92335, United States
  • Adventist Health Glendale
    Glendale, California 91206, United States
  • Kaiser Permanente South Bay Medical Center
    Harbor City, California 90710, United States
  • UCSD Medical Center - La Jolla
    La Jolla, California 92037, United States
  • Kaiser Permanente Los Angeles
    Los Angeles, California 90027, United States
  • University of Southern California Medical Center
    Los Angeles, California 90033, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Cedars-Sinai Marina Del Rey Hospital
    Marina Del Rey, California 90292, United States
  • Kaiser Permanente - Ontario
    Ontario, California 91761, United States
  • Stanford University Medical Center
    Palo Alto, California 94304, United States
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
  • Sutter Medical Group, Neurology
    Sacramento, California 95816, United States
  • UCSD - Hillcrest; Hillcrest Medical Center
    San Diego, California 92103, United States
  • CPMC - Van Ness Campus
    San Francisco, California 94109, United States
  • CPMC - Davies Campus
    San Francisco, California 94114, United States
  • Torrance Memorial Medical Center
    Torrance, California 90505, United States
  • John Muir Medical Center-Walnut Creek
    Walnut Creek, California 94598, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • University of Florida Health at Shands
    Gainesville, Florida 32608, United States
  • Baptist Medical Center - Jacksonville
    Jacksonville, Florida 32207-8202, United States
  • Baptist Medical Center-South
    Jacksonville, Florida 32258, United States
  • Jackson Memorial Hospital
    Miami, Florida 33136, United States
  • The Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453, United States
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
  • St. Catherine Hospital
    East Chicago, Indiana 46312, United States
  • St. Mary Medical Center
    Hobart, Indiana 46432, United States
  • Community Hospital
    Munster, Indiana 46321, United States
  • Uni of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Baptist Health Corbin
    Corbin, Kentucky 40701, United States
  • Baptist Health Lexington
    Lexington, Kentucky 40503, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Johns Hopkins
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Univ of Michigan Medical Ctr
    Ann Arbor, Michigan 48109-0718, United States
  • Henry Ford Macomb Hospital - Clinton Township
    Clinton Township, Michigan 48038, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • McLaren Flint
    Flint, Michigan 48532, United States
  • Spectrum Health Hospitals
    Grand Rapids, Michigan 49503, United States
  • ProMedica Monroe Regional Hospital
    Monroe, Michigan 48162, United States
  • Fairview Ridges Hospital
    Burnsville, Minnesota 55337, United States
  • Fairview Southdale
    Edina, Minnesota 55435, United States
  • U of Minnesota MedCtr Fairview
    Minneapolis, Minnesota 55455, United States
  • Sanford Worthington Medical Center
    Worthington, Minnesota 56187, United States
  • Washington University
    Saint Louis, Missouri 63128, United States
  • JFK Neuroscience Institute
    Edison, New Jersey 08820, United States
  • Atlantic Health System - Overlook Medical Center
    Summit, New Jersey 07901, United States
  • Capital Health Regional Medical Center
    Trenton, New Jersey 08638, United States
  • Buffalo General Medical Center
    Buffalo, New York 14203, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Mission Hospitals Inc
    Asheville, North Carolina 28803, United States
  • Guilford Neurologic Research
    Greensboro, North Carolina 27405, United States
  • Univ of Cincinnati
    Cincinnati, Ohio 45219, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Riverside Methodist Hospital; Cancer Services
    Columbus, Ohio 43214-1419, United States
  • Grant Medical Center
    Columbus, Ohio 43215, United States
  • Doctors Hospital
    Columbus, Ohio 43228, United States
  • ProMedica Toledo Hospital
    Toledo, Ohio 43606, United States
  • Ascension St. John
    Tulsa, Oklahoma 74104, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • Adventist Health Portland
    Portland, Oregon 97216, United States
  • Providence Saint Vincent's Medical Center
    Portland, Oregon 97225, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • UPMC East Hospital
    Monroeville, Pennsylvania 15146, United States
  • Penn Presbyterian Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • Uni of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Pennsylvania Hospital
    Philadelphia, Pennsylvania 19107, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • UPMC Mercy
    Pittsburgh, Pennsylvania 15219, United States
  • UPMC Passavant Hospital
    Pittsburgh, Pennsylvania 15237, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Sanford Neurology Clinic
    Sioux Falls, South Dakota 57104, United States
  • Chattanooga Center for Neurologic Research
    Chattanooga, Tennessee 37404, United States
  • Saint Thomas Rutherford Hospital
    Murfreesboro, Tennessee 37129, United States
  • Saint Thomas Health
    Nashville, Tennessee 37205, United States
  • Saint Thomas Midtown Hospital
    Nashville, Tennessee 37232, United States
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
  • Dell Seton Medical center at the University of Texas
    Austin, Texas 78701, United States
  • Seton Medical Center Austin
    Austin, Texas 78705, United States
  • Valley Baptist Medical Center-Brownsville
    Brownsville, Texas 78520, United States
  • Baylor University Medical Center
    Dallas, Texas 75231, United States
  • Valley Baptist Medical Center
    Harlingen, Texas 78550, United States
  • University of Texas at Houston; Neurology
    Houston, Texas 77030, United States
  • Ascension Seton Hays
    Kyle, Texas 78640, United States
  • Ascension Seton Williamson
    Round Rock, Texas 78665, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • University of Virginia
    Charlottesville, Virginia 22906, United States
  • Uni of Alberta
    Edmonton, Alberta T6G 2G3, Canada
  • Hamilton General Hospital; Pharmacy
    Hamilton, Ontario L8L 2X2, Canada
  • Montreal Neurological Inst; Clinical Research Unit
    Montreal, Quebec H3A 2B4, Canada
09

References and documents

Publications

  • Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4. PubMed 35369714 ↗

Study documents

  • Study protocol · Mar 9, 2021
  • Statistical analysis plan · Mar 29, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03785678
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Dec 24, 2018
Start date
Mar 2, 2019
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Results posted
May 22, 2024
Last update
May 22, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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