Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2020-01-31

Brief Summary

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A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure \<185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target \<130 mm Hg.

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Detailed Description

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Patients will be followed for 3 months:

* inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
* within 24 hours after reperfusion: blood pressure measurements
* at 24 hours: measurement of blood pressure (T0 + 24 h and evaluation of the NIHSS score.
* Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). For some centers: Cerebral MRI without injection between H24 and H36
* 72 hours after reperfusion: Cerebral scanner in case of hyperdensity on the initial scanner
* 3 months after reperfusion: disability assessment by Rankin score

Conditions

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Acute Stroke Blood Pressure Cerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive blood pressure management

Group Type EXPERIMENTAL

Systolic blood pressure target < 130 mm Hg

Intervention Type OTHER

Adaptation of antihypertensive treatments to reach the Systolic blood pressure target \< 130 mm Hg

Standard blood pressure management

Group Type ACTIVE_COMPARATOR

Systolic blood pressure target < 185 mm Hg

Intervention Type OTHER

Adaptation of antihypertensive treatments to reach the Systolic blood pressure target \< 185 mm Hg

Interventions

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Systolic blood pressure target < 130 mm Hg

Adaptation of antihypertensive treatments to reach the Systolic blood pressure target \< 130 mm Hg

Intervention Type OTHER

Systolic blood pressure target < 185 mm Hg

Adaptation of antihypertensive treatments to reach the Systolic blood pressure target \< 185 mm Hg

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Intracranial Occlusion of internal carotid arteries and/or proximal middle cerebral (segment M1) diagnosis made on initial Imaging.
* Reperfusion after a thrombectomy procedure (defined by a 2b-3 TICI score -Thrombolysis In Cerebral Infarction- score).

Exclusion Criteria

* Per-procedure hemorrhagic complications (prior to reperfusion)
* Systolic blood pressure at baseline \<130 mm Hg within one hour of recanalization
* Pre-existing stroke handicap defined by a Rankin score (modified scale, mRS)\> 3
* Hemodynamically significant carotid stenosis
* Occlusion of the isolated cervical carotid artery
* Known pregnancy
* Legal protection
* Non-affiliation to a social security scheme
* Refusal of the patient (or of his / her relatives in case of urgent inclusion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No