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

Blood Pressure Clinical Trial

— BP-TARGET  

Official title:

Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160677
• Other study ID #: MMI_2016_26
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: August 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Stroke
• Blood Pressure
• Cerebral Hemorrhage
• Hemorrhage
• Stroke

Intervention

Other:
• Systolic blood pressure target < 130 mm Hg
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg
• Systolic blood pressure target < 185 mm Hg
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon	Lyon
France	Centre Hospitalier Régional Universitaire	Nancy
France	Fondation Ophtalmologique A de Rothschild	Paris
France	Hopital Lariboisière	Paris
France	Hopital Foch	Suresnes
France	Hopital de purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scan performed between 24 and 36 hours after thrombectomy