NCT02157532: EASI

Intra-arterial Thrombectomy as an Acute Treatment Intervention for Stoke: the Endovascular Acute Stoke Intervention (EASI) Trial

Suspended NA Last updated 10 September 2024

What this trial tests

NA trial testing mechanical thrombectomy in Stroke, Acute in 480 participants. Suspended.

Timeline

1 January 2013

Primary endpoint
1 January 2025

1 January 2026

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	1 January 2013
Primary completion	1 January 2025
Estimated completion	1 January 2026
Sites	2 locations across Canada

Drugs / interventions tested

• mechanical thrombectomy — full drug profile →
• Best standard treatment — full drug profile →

Conditions studied

• Stroke, Acute — all drugs for Stroke, Acute →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

18 and older, any sex, with Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• clinical (efficacy): favorable modified Rankin Score (less than or equal to 2)
  Time frame: 3 months
  The efficacy of mechanical thrombectomy compared to standard stroke treatment will be evaluated using the modified Rankin scale score at 3 months. This measure includes the rate of death within 3 months
• Rate of symptomatic intracranial hemorrhage
  Time frame: 24 hours
  the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded

Sponsor's own description

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.

Publications & conference data

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

1. Early CT changes in patients admitted for thrombectomy: Intrarater and interrater agreement.
   Farzin B, Fahed R, Guilbert F, Poppe AY, et al · · 2016 · cited 113× · PMID 27316243 · DOI 10.1212/wnl.0000000000002860
2. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial.
   Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, et al · · 2017 · cited 45× · PMID 28238522 · DOI 10.1016/j.neurad.2017.01.126
3. Diagnosis and management of <i>tandem</i> occlusion in acute ischemic stroke.
   Di Donna A, Muto G, Giordano F, Muto M, et al · · 2023 · cited 23× · PMID 37609048 · DOI 10.1016/j.ejro.2023.100513
4. A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy.
   Poppe AY, Jacquin G, Stapf C, Daneault N, et al · · 2020 · cited 14× · PMID 31563589 · DOI 10.1016/j.neurad.2019.08.003
5. A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care.
   Fahed R, Finitsis S, Khoury N, Deschaintre Y, et al · · 2018 · cited 12× · PMID 30231915 · DOI 10.1186/s13063-018-2870-6
6. Practicing outcome-based medical care using pragmatic care trials.
   Darsaut TE, Raymond J. · · 2020 · cited 5× · PMID 33121523 · DOI 10.1186/s13063-020-04829-7
7. Endovascular Treatment Combined With Standard Medical Treatment Improves Outcomes of Posterior Circulation Stroke: A Systematic Review and Meta-Analysis.
   Dong S, Li Y, Guo J, Luo Y, et al · · 2022 · cited 3× · PMID 35518202 · DOI 10.3389/fneur.2022.694418
8. European Stroke Organisation Conference: Abstracts
   · 2018