Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window

NCT04256096 | Unknown Phase 3 DMC

• 1 other identifier: 17877519.6.1001.5327
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 14

Brief Summary

A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well

Conditions

Stroke, Ischemic

Keywords

stroke; ischemic stroke; thrombectomy; treatment; acute stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale scores

  Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days

  90 days

Secondary Outcomes (6)

• Proportion of Patients with Functional independence in 90 days

  90 days

• Disability on the utility-weighted modified Rankin scale (UW-mRS)

  90 days

• Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D)

  90 days and 1 year

• Mortality at 90 days

  90 days

• Proportion of patients with Intracranial Hemorrhage at 24 hours

  24 hours

Study Arms (2)

thrombectomy

EXPERIMENTAL

mechanical thrombectomy with stent-retriever and/or thromboaspiration

Device: Thrombectomy

Clinical treatment

ACTIVE COMPARATOR

Best Medical treatment

Device: Thrombectomy

Interventions

Thrombectomy DEVICE

Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)

Also known as: Endovascular treatment

Clinical treatment; thrombectomy

Eligibility Criteria

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

You may qualify if:

• Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
• No significant pre-stroke functional disability (mRS ≤2)
• Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
• Age ≥18 years (no upper age limit)
• Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
• The presence of Age-Adjusted modified Clinical ASPECTS Mismatch (mCAM) defined as ASPECTS 5-10 and one of the following criteria:
• NIHSS ≥ 8 and \>50% involvement in 0-1 Cortical (e.g. M1-6) ASPECTS areas (any age);
• NIHSS ≥ 8 and \>50% involvement in 0-2 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old);
• NIHSS ≥ 15 and \>50% involvement in 0-3 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old).
• Patient treatable within 6-24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture.
• Informed consent obtained from patient or acceptable patient surrogate

You may not qualify if:

• Clinical criteria
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
• Baseline platelet count \< 30.000/µL
• Baseline blood glucose of \< 50mg/dL
• Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
• Patients in coma defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life-threatening allergy (more than rash) to contrast medium
• Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms
• Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Cerebral vasculitis
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
• Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Hospital das Clínicas de Ribeirão Preto: collaborator
• Hospital Geral de Fortaleza: collaborator
• Hospital de Base: collaborator
• Federal University of São Paulo: collaborator
• Fundação Faculdade Regional de Medicina de São José do Rio Preto: collaborator
• UPECLIN HC FM Botucatu Unesp: collaborator
• University of Campinas, Brazil: collaborator
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator
• Universidade Federal do Paraná: collaborator
• Hospital Estadual Central: collaborator
• Hospital Sao Jose do Avai: collaborator
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator
• Federal University of Uberlandia: collaborator
• Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo: collaborator

Study Sites (14)

Hospital Geral de Fortaleza

Fortaleza, Ceará, Brazil

RECRUITING

Associacao Congregacao de Santa Catarina

Vitória, Espírito Santo, 29050-335, Brazil

RECRUITING

Hospital de Base

Brasília, Federal District, Brazil

RECRUITING

Hospital das Clínicas de Uberlândia

Uberlândia, Minas Gerais, Brazil

RECRUITING

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

NOT YET RECRUITING

Conferencia Sao jose do Avai

Itaperuna, Rio de Janeiro, Brazil

NOT YET RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035007, Brazil

RECRUITING

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

Porto Alegre, Rio Grande do Sul, Brazil

NOT YET RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

NOT YET RECRUITING

Hospital de Clínicas - UNICAMP

Campinas, São Paulo, Brazil

NOT YET RECRUITING

Hospital das Clinicas de Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina S J Rio Preto

São José do Rio Preto, São Paulo, Brazil

NOT YET RECRUITING

Instituto de Assistência Médica ao Servidor Público Estadual de Sao Paulo

São Paulo, São Paulo, Brazil

NOT YET RECRUITING

Universidade Federal de São Paulo - UNIFESP/EPM

São Paulo, São Paulo, Brazil

NOT YET RECRUITING

Related Publications (1)

• Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.

  PMID: 34850380 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raul G Nogueira, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Sheila CO Martins, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila CO Martins, MD, PhD

CONTACT

51999628467; scmartins@hcpa.edu.br

Natacha Fleck

CONTACT

51992699829; pesquisaneurovascular@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators. For the primary endpoint, subjects will be followed for 90 days post-randomization. Distribution of the modified Rankin Scale scores at 90 days will be evaluated by two separate assessors who are blinded to treatment. Primary Endpoint will consider central core lab readings only (video interview with RFA method) with local reading as a back-up mechanism.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: March 9, 2020
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after de publication for 6 months
• Access Criteria: Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigators

Locations

BR (14)