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

Fondation Ophtalmologique Adolphe de Rothschild320 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

320

Conditions

Acute Stroke Blood Pressure Cerebral Hemorrhage

Interventions

Systolic blood pressure target < 130 mm HgOTHER

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

Systolic blood pressure target < 185 mm HgOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (7)

CHU de Bordeaux

Bordeaux, France

Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon

Lyon, France

Centre Hospitalier Régional Universitaire

Nancy, France

Hopital Lariboisière

Paris, France

Outcomes

Primary Outcomes

Rate of patients with intracranial hemorrhagic complications

Rate of patients with intracranial hemorrhagic complications (Symptomatic or asymptomatic) on cerebral scan, evaluated with a double centralized blind reading

Time frame: Scan performed between 24 and 36 hours after thrombectomy

Data from ClinicalTrials.gov

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