Endovascular Acute Stroke Intervention Trial - the EASI Trial

NCT02157532 | Suspended DMC

• 1 other identifier: CE 12.224
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke, Acute

Keywords

Severe stroke; IV tPA; mechanical thrombectomy

Outcome Measures

Primary Outcomes (2)

• clinical (efficacy): favorable modified Rankin Score (less than or equal to 2)

  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

  3 months

• Rate of symptomatic intracranial hemorrhage

  the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded

  24 hours

Secondary Outcomes (4)

• Infarct evolution

  24 hours

• Angiographic outcome in patients allocated to mechanical thrombectomy

  2 hours

• Frequency and Severity of complications

  3 months

• Rate of intracranial hemorrhage

  24 hours

Study Arms (2)

Best standard treatment

ACTIVE COMPARATOR

intravenous r-tPA or any other medical management

Drug: Best standard treatment

Mechanical thrombectomy

ACTIVE COMPARATOR

Endovascular mechanical thrombectomy with stent-retrievers

Procedure: mechanical thrombectomy

Interventions

mechanical thrombectomy PROCEDURE

Mechanical thrombectomy using any already approved stent-retriever device

Mechanical thrombectomy

Best standard treatment DRUG

Intravenous r-tPA infusion or any other medical management option

Also known as: Medical management

Best standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18
• NIHSS greater than or equal to 8
• onset of symptoms is less than 5 hours OR symptom/imaging mismatch
• suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.

You may not qualify if:

• established infarction of the target symptomatic territory
• co-morbid diseases which suggest a poor 90 day outcome irrespective of management
• radiologic evidence of hemorrhagic transformation of the infarcted territory

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (2)

• Poppe AY, Jacquin G, Stapf C, Daneault N, Deschaintre Y, Gioia LC, Odier C, Labrie M, Nehme A, Nico L, Roy D, Weill A, Raymond J. A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy. J Neuroradiol. 2020 Nov;47(6):416-420. doi: 10.1016/j.neurad.2019.08.003. Epub 2019 Sep 26.

  PMID: 31563589 DERIVED

• Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Poppe AY, Odier C, Lebrun LH, Guilbert F, Gentric JC, Batista A, Weill A, Roy D, Bracard S, Raymond J; EASI trial collaborators. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol. 2017 Jun;44(3):198-202. doi: 10.1016/j.neurad.2017.01.126. Epub 2017 Feb 24.

  PMID: 28238522 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Jean Raymond, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Serge Bracard, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 6, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (2)