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

Not Applicable

Completed

• Conditions: Cerebral Hemorrhage; Blood Pressure; Acute Stroke
• Interventions: Other: Systolic blood pressure target < 130 mm Hg; Other: Systolic blood pressure target < 185 mm Hg

• Registration Number: NCT03160677
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-06-21
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive blood pressure management	Systolic blood pressure target < 130 mm Hg	-
Standard blood pressure management	Systolic blood pressure target < 185 mm Hg	-

Primary Outcome Measures

Name	Time	Method
Rate of patients with intracranial hemorrhagic complications	Scan performed between 24 and 36 hours after thrombectomy	Rate of patients with intracranial hemorrhagic complications (Symptomatic or asymptomatic) on cerebral scan, evaluated with a double centralized blind reading

Trial Locations

Locations (7)

Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hopital Foch; 🇫🇷 Suresnes, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Régional Universitaire; 🇫🇷 Nancy, France

Hopital Lariboisière; 🇫🇷 Paris, France

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France

Hopital de purpan; 🇫🇷 Toulouse, France