Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy

Completed

• Conditions: Stroke

• Registration Number: NCT04553237
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. This advanced age leads to a high risk of mortality, long hospitalization, causing neurological sequelae in most cases.

Neurological handicap in the elderly is due to a high rate of comorbidity, reduced neuronal plasticity, nutritional status, and the short time to convert the penumbra area to ischemia.

Currently the standard treatment for the acute phase of HF is thrombolysis or thrombectomy.

The principle of thrombolysis is based on the use of a thrombolytic drug (Actylise®). It is a tissue plasminogen activator (t-PA) that will cause lysis and dissolution of clots blocking the artery. Thrombolysis is recommended until 4:30 a.m. after the onset of symptoms in the absence of contraindication.

Mechanical thrombectomy consists of removing the blood clot by introducing a probe into the artery having a proximal carotid or sylvic occlusion in its M1 portion or in the vertebro-basilar territory of an indeterminate schedule of less than 24 hours or determined from 6 hours to 24 hours having a radio-clinical mismatch, according to the DAWN study. The results of this study were analyzed according to age, NIHSS score and lesion volume on perfusion scanner or MRI (RAPID software). The interim analysis at 31 months on 206 randomized patients (107 thrombectomies versus 99 medical treatments alone) showed a clear superiority of the thrombectomy, leading to the premature end of the study, over the handicap at 3 months with more than 35 % of independent patients.

In most of the randomized studies, patients over 90 years of age have been excluded or are under-represented. This lack of data therefore does not make it possible to determine the effectiveness of thrombolysis or thrombectomy treatments in these patients.

A recent meta-analysis has shown that the functional recovery in these patients treated by thrombectomy is superior to those of the same age without thrombectomies. According to American studies, the advanced age of a patient is not a contraindication to this treatment.

Patients affected by a cerebral infarction represent 40 to 50% of hospitalizations in the neurology department of the Groupe Hospitalier Paris Saint-Joseph. In the intensive care of the neuro-vascular unit, the patient is received as quickly as possible to decide whether he can benefit from an extreme emergency treatment (intravenous thrombolysis or thrombectomy).

The present study should show that the clinical course after treatment in patients over 90 years of age is substantially comparable to younger patients, and that age is not a contraindication to treatment in the acute phase of stroke in the elderly.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-11
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Primary Completion: 2021-03-31
• Status Verified: 2023-04
• Study Completion: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Patient over 70 years old
• Patient treated in the neurology department of Paris Saint-Joseph hospital for a stroke between 2017 and 2019
• Patient treated by thrombolysis less than 4:30 after the onset of symptoms and / or by mechanical thrombectomy less than 24 hours.
• French-speaking patient

Exclusion Criteria

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of their data for this research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Management of stroke between two groups of patients.	Day 90	This outcome corresponds to the comparaison of functional recovery at D90 after a stroke as measured by the Modified Rankin scale for measuring the degree of disability or dependence in the daily activities of patients.; 0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.

Secondary Outcome Measures

Name	Time	Method
Intra-hospital mortality	Day 90	This outcome corresponds to the rate of patients with in-hospital mortality.
Symptomatic hemorrhagic changes	Day 90	This outcome corresponds to the rate of patients with hemorrhagic transformation.
Other complications	Day 90	This outcome corresponds to the rate of patients presenting others complications during hospitalisation.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France