Trials

MANAGEMENT OF STROKE IN THE NEUROCRITICAL CARE UNIT
SDC 4-1 Compilation of Landmark Trials in the Treatment of Acute Ischemic Stroke,
Inclusion/Exclusion Criteria, and Clinical Measures and Outcomes
Absolute Risk
Reduction
(Modified
Trial (Time to Treat in Rankin Scale
Hours) Inclusion/Exclusion Criteria Thrombectomy Score ≤2)
NINDS-rtPA (National Inclusion No 8%
Institute of Neurological
18–80 years
Disorders and Stroke–
Recombinant Tissue Clinical diagnosis of ischemic stroke with a
Plasminogen Activator)11 measurable disabling neurologic deficit
(<3 hours) Exclusion (absolute)
Uncontrolled hypertension (>185/
>110 mm Hg despite treatment)
Known arteriovenous malformation,
neoplasm, or aneurysm
Acute bleeding tendencies
Platelet count <100,000/mm3
Heparin received in prior 48 hours with
elevated partial thromboplastin time
Current use of an anticoagulant (warfarin) with
an international normalized ratio (INR) of >1.7
Intracranial or spinal surgery, head trauma, or
previous stroke within prior 3 months
Arterial puncture at noncompressible site within
last 7 days
Evidence of intracranial hemorrhage on CT
CT shows multilobar infarction (hypodensity
greater than 1/3 cerebral hemisphere)
Exclusion (relative)
Witnessed seizure at stroke onset
National Institutes of Health Stroke Scale (NIHSS)
score of >22 (severe deficit) or <4 and no dysphasia
(mild deficit) or rapidly improving symptoms
(spontaneous clearing)
14 days postoperative or posttrauma
Recent gastrointestinal or urinary tract hemorrhage
(prior 21 days)
Recent acute myocardial infarction (prior 3 months)
Post–myocardial infarction pericarditis
Glucose <50 mg/dL or >400 mg/dL
ECASS III (European Inclusion No 7%

Cooperative
Same as NINDS-rtPA trial
Acute Stroke Study III)12
(3–4.5 hours) Exclusion
Same as NINDS-rtPA except for a history of
ischemic stroke and diabetes mellitus
V O L . 24 , N O . 6 ( D E C E M B E R 2 0 1 8 ) : N E U R O C R I T I C A L C A R E
Symptomatic Intracranial
Number of Reperfusion (Thrombolysis in Cerebral Number of Participants Hemorrhage (Treatment
Participants Infarction [TICI] Grade 2B or greater) Needed to Treat Versus Control in Percent)
624 Unavailable 12 6% versus 2%
821 Unavailable 14 8% versus 3.5%

Absolute Risk
Reduction
(Modified
IST-3 (Third International Inclusion No 3%
Stroke Trial)13 (<6 hours)
Same as NINDS-rtPA trial except no limit for age
Exclusion
MRI-guided Thrombolysis Inclusion No 11.5%

for Stroke With Unknown
Same as NINDS-rtPA trial in addition to the following:
Time of Onset14 (led by
WAKE-UP investigators) Last time known well more than 4.5 hours
Mismatch between the presence of an abnormal
signal on MRI diffusion-weighted imaging (DWI) and
no visible signal change on fluid-attenuated
inversion recovery (FLAIR)
Exclusion
Same as NINDS-rtPA trial in addition to planned
thrombectomy and NIHSS score of >25
Tenecteplase Versus Inclusion Yes Nonsignificant

Alteplase Before
Same as NINDs-rtPA trial in addition to the following: 13% (P=.06)
Thrombectomy for
Ischemic Stroke15 CT angiography showing occlusion of internal
(led by EXTEND-IA TNK carotid artery, first or second segment middle
investigators) cerebral artery (MCA) or basilar artery
Treatment to retrieve clot should commence within
6 hours of symptoms
CT perfusion mismatch for anterior circulation
strokes (first 80 patients)
Exclusion
MR CLEAN (Multicenter Inclusion Yes 14%

Randomized Clinical
Same as NINDs-rtPA trial in addition to the following:
Trial of Endovascular
Treatment for Acute NIHSS score of ≥2
Ischemic Stroke)16 CT angiography demonstrates large vessel
(<6 hours) occlusion in MCA, anterior cerebral artery, or
internal carotid artery
Onset of symptoms <6 hours
Baseline modified Rankin Scale score of ≤1
Exclusion
503 Unavailable 9 20% versus 12% (NINDS

criteria)
202 22% with tenecteplase versus 11% with rtPA 10 for improved perfusion; 1% in both groups
(perfusion of >50% territory at the time of clinical ordinal scale analysis
angiographic assessment) of modified Rankin Scale
shows nonsignificant
difference between the
groups
500 59% 7 7.7% versus 6.4%

Absolute Risk
Reduction
(Modified
ESCAPE (Endovascular Inclusion Yes 24%
Treatment for Small Core
Same as NINDs-rtPA trial and an NIHSS score of >5
and Anterior Circulation
Proximal Occlusion With Exclusion
Emphasis on Minimizing Same as NINDS-rtPA trial
CT to Recanalization
Times)17 (<12 hours)
EXTEND-IA (Extending the Inclusion Yes 31%

Time for Thrombolysis in
Same as NINDs-rtPA trial as well as the following:
Emergency Neurological
Deficits—Intra-arterial)18 Symptom onset <8 hours
(<8 hours) CT angiography demonstrates large vessel
occlusion in MCA, anterior cerebral artery, or
Mismatch: using CT or MRI with a Tmax >6 second
delay perfusion volume and either CT–regional
cerebral blood flow or DWI infarct core volume: (1)
mismatch ratio of greater than 1.2, and (2) absolute
mismatch volume of greater than 10 mL, and (3)
infarct core lesion volume of less than 70 mL
Exclusion
Same as NINDS-rtPA trial in addition to the following:
Baseline noncontrast CT reveals a moderate/large
core defined as extensive early ischemic changes
of Alberta Stroke Program Early CT Score (ASPECTS)
of 0–5 in the territory of symptomatic intracranial
occlusion
Other confirmation of a moderate to large core
defined one of three ways: (1) On a single phase,
multiphase, or dynamic CT angiogram: no or minimal
collaterals in a region greater than 50% of the MCA
territory when compared to pial filling on the
contralateral side (multiphase/dynamic CT
angiography preferred) OR (2) on CT perfusion
(>8 cm coverage): a low cerebral blood volume and
very low cerebral blood flow ASPECTS of <6 AND in
the symptomatic MCA territory OR (3) on CT
perfusion (<8 cm coverage): a region of low
cerebral blood volume and very low cerebral blood
flow of more than one-third of the CT perfusion
imaged symptomatic MCA territory
315 72% 4 3.6% versus 2.9%
70 86% 3 0% versus 6%
Absolute Risk
Reduction
(Modified
SWIFT-PRIME (Solitaire Inclusion Yes 24%
With the Intention for
Same as NINDs-rtPA trial except for the following:
Thrombectomy as Primary
Endovascular Treatment)19 Symptom onset <6 hours.
(<6 hours) CT angiography demonstrates large vessel
occlusion in MCA, anterior cerebral artery, or
NIHSS score of 8–30
Exclusion
REVASCAT (Randomized Inclusion Yes 16%

Trial of Revascularization
Same as NINDS-rtPA trial except for the following:
With Solitaire FR Device
Versus Best Medical Onset of symptoms <8 hours
Therapy in the Treatment Intracranial large vessel occlusion
of Acute Stroke Due to
Anterior Circulation Large Baseline modified Rankin Scale score of ≤1
Vessel Occlusion Exclusion
Presenting Within
8 Hours of Symptom
Onset)20 (<8 hours) INR >3.0
Platelet count < 30,000/μmm3
Patients in coma
Life-threatening allergy to contrast medium
Inaccessible vessel via endovascular treatment
196 88% 4 0% versus 3%
206 66% 7 1.9% versus 1.9%

Absolute Risk
Reduction
(Modified
DWI or CT Perfusion Inclusion Yes 36%
Assessment With Clinical
Mismatch in the Triage of
Wake-up and Late NIHSS score of ≥10
Presenting Strokes Less than one-third of MCA territory involved, as
Undergoing evidenced by CT or MRI
Neurointervention With
Trevo21 (<24 hours) (led by Occlusion of the intracranial internal carotid artery
DAWN investigators) and/or MCA/first segment of MCA, as evidenced
by MRA or CT angiography
Clinical imaging mismatch defined as one of the
following on RAPID (automated MRI analysis
software) magnetic resonance DWI or CT
perfusion–regional cerebral blood flow maps: (1)
0–20 cc core infarct and NIHSS score of ≥10 (and
age ≥80 years old); (2) 0–30 cc core infarct and
NIHSS score of ≥10 (and age <80 years old); (3) 31 cc
to <50 cc core infarct and NIHSS score of ≥20 (and
age <80 years old)
Internal carotid artery or MCA/first segment of
MCA occlusion (carotid occlusions can be cervical
or intracranial; with and/or without tandem MCA
lesions) by MRA or CT angiography
Target mismatch profile on CT perfusion or MRI
(ischemic core volume is <70 mL, mismatch ratio is
>1.8 and mismatch volume is >15 mL)
Exclusion
Same as NINDs-rtPA trial
206 84% 3 6% versus 3%
Absolute Risk
Reduction
(Modified
DEFUSE-3 (Diffusion and Inclusion Yes 28%
Perfusion Imaging
Evaluation for
Understanding Stroke NIHSS score of ≥6
Evolution 3)22 (6–16 hours) Less than one-third of the MCA territory involved,
as evidenced by CT or MRI
Occlusion of the intracranial internal carotid artery
and/or MCA/first segment of MCA, as evidenced
by MRA or CT angiography
Clinical imaging mismatch defined as one of the
following on RAPID (automated MRI analysis
software) magnetic resonance DWI or CT
perfusion–regional cerebral blood flow maps: (1)
0–20 cc core infarct and NIHSS score of ≥10 (and
age ≥80 years old); (2) 0–30 cc core infarct and
NIHSS score of ≥10 (and age <80 years old); (3) 31 cc
to <50 cc core infarct and NIHSS score of ≥20
(and age <80 years old)
Exclusion
ASPECTS <6
CT = computed tomography; MRA = magnetic resonance angiography; MRI = magnetic resonance imaging; Tmax = time to maximum plasma
concentration of the contrast.

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MANAGEMENT OF STROKE IN THE NEUROCRITICAL CARE UNIT

ECASS III (European Inclusion No 7%

821 Unavailable 14 8% versus 3.5%

MRI-guided Thrombolysis Inclusion No 11.5%

Tenecteplase Versus Inclusion Yes Nonsignificant

MR CLEAN (Multicenter Inclusion Yes 14%

503 Unavailable 9 20% versus 12% (NINDS

500 59% 7 7.7% versus 6.4%

EXTEND-IA (Extending the Inclusion Yes 31%

REVASCAT (Randomized Inclusion Yes 16%

206 66% 7 1.9% versus 1.9%

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