Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT02157532 |
| Other study ID # |
CE 12.224 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
January 2026 |
Study information
| Verified date |
August 2023 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Stroke constitutes the primary cause of acquired disability in adults and the second cause of
dementia following Alzheimer disease. It has been shown that patients with a moderate to
severe clinical score have occlusion of brain large vessels, resulting in a worse clinical
outcome. Many studies have demonstrated that early recanalization after IV rtPA is more
restricted, the larger and more proximal the artery. Several systems for mechanical
intracranial arterial thrombectomy of large trunks have recently been proposed and are now
available. Potential advantages of these mechanical systems on chemical thrombolysis are
speed (a few minutes versus 1 hour) and absence of thrombolytic injection.
The objective of the EASI trial is thus to:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in
patients treated with IV thrombolysis or in patients for whom thrombolysis is
contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is
superior to standard treatment alone within 5 h of the appearance of symptoms, in
patients with occlusion of proximal cerebral arteries following moderate to severe
stroke (NIHSS larger than or equal to 8), evaluated at 3 months.
The design is a randomized, controlled multicentric trial, with a parallel comparison between
standard and combined (standard plus thrombectomy) treatment.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary
hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal
to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3
months.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is
carried out with already approved devices, according to the manufacturer's instructions,
following a diagnostic cerebral angiography.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3
months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage
at 24 hours.
If the primary hypothesis is validated, expected benefits of this study is a higher rate of
autonomy for stroke patients with all the attendant consequences: reduction in hospital
stays, and a faster return to the activities of daily life.
Description:
Background Stroke constitutes the primary cause of acquired disability in adults and the
second cause of dementia following Alzheimer disease. The burden of disease may be
substantial since 25% of the victims of stroke are younger than 65 years. Standard treatment
is IV rtPA thrombolysis, within 3-4.5 hours of first signs. It has been shown that patients
with a moderate to severe clinical score (NIHSS more than 10) have occlusion of proximal
large vessels, resulting in a more adverse clinical outcome. Many studies have demonstrated
that early recanalization after IV rtPA is more restricted, the larger and more proximal the
artery. Recanalization of large arteries occurs more frequently and earlier (leading to
better prognosis) with arterial than with venous access. Biochemical arterial treatment
appears thus of greater efficacy in terms of recanalization of large vessels, but more
inconvenient with respect to setup delays. Several systems for mechanical intracranial
arterial thrombectomy of large trunks have recently been proposed and are now available.
Results of short case series and prospective multicentric non randomized studies appear
favorable. The thrombus obstructing the artery is reached by endovascular means and
mechanically removed with the result that orthograde blood flow is re-established in the
cerebral territory involved in the ischemia. Potential advantages of these mechanical systems
on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic
injection. Mechanical thrombolysis should thus lead to better results than injection of an
arterial thrombolytic agent, as well as increase the time window for treatment. In addition,
hemorrhagic complications should be reduced.
Objectives
In situations where IV rtPA thrombolysis is not optimal, that is in presumed embolic
occlusions of large intracranial arterial trunks (terminal carotid, initial segment of the
MCA, distal third of the basilar trunk) with a moderate to severe clinical state (NIHSS
greater or equal to 8) and in situations when IV rtPA may be contra-indicated:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in
patients treated with IV thrombolysis or in patients for whom thrombolysis is
contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is
superior to standard treatment alone within 5 h of the appearance of symptoms, in
patients with occlusion of proximal cerebral arteries following moderate to severe
stroke (greater or equal to 8), evaluated at 3 months.
Design EASI is a randomized, controlled multicentric trial, with a parallel comparison
between standard and combined (standard plus thrombectomy) treatment. All adults presenting
less than 5 hours after the beginning of symptoms with an NIHSS greater or equal to 8
discordant with imaging data are eligible. Occlusion site, when available, includes
intracranial carotid artery, M1 segment of middle cerebral and basilar artery.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary
hypothesis of a 15% difference in number of subjects with a favorable mRS (greater than 2) at
3 months, with the assumption of a 25% efficacy (mRS less or equal to 2) for IV thrombolytic
treatment at 3 months.
Randomization may take place any time following admission, including during IV thrombolysis.
The choice of early randomization, without knowledge of the clinical or angiographic results
of IV thrombolysis fulfils several objectives: allow timely delivery of a proven treatment;
prevent unnecessary exposure to angiography risks; set up thrombectomy as fast as possible
for a maximal efficacy.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is
carried out with already approved devices, according to the manufacturer's instructions,
following a diagnostic cerebral angiography.
Follow-up includes brain imaging and the mRS at 3 months.
Endpoint measures include:
- Clinical endpoints as measured by the neurologist, and include the NIHSS at baseline and
the mRS at 3 months.
- Safety data: complications, death at 3 months, hemorrhage according to 24 hours CT scan.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3
months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage
at 24 hours.
Secondary efficacy endpoints include:
- Comparison of ASPECTS score between baseline and 24 hours CT scans
- In thrombectomy group, blood flow in treated territory as measured by a TICI reperfusion
score of 2 or 3 at end of treatment.
Secondary safety endpoints include
- Rate of hemorrhage on 24 hours CT scan
- Frequency and severity of complications of standard treatment
- Frequency and severity of arterial complications in thrombectomy group
- Frequency and severity of complications at puncture site in thrombectomy group
