BP-TARGET: Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT03160677

Collaborator

(none)

320

Enrollment

Locations

Arms

31.3

Actual Duration (Months)

45.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke Blood Pressure Cerebral Hemorrhage	Other: Systolic blood pressure target < 130 mm Hg Other: Systolic blood pressure target < 185 mm Hg	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 21, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive blood pressure management	Other: Systolic blood pressure target < 130 mm Hg Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg
Active Comparator: Standard blood pressure management	Other: Systolic blood pressure target < 185 mm Hg Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg

Arm

Intervention/Treatment

Experimental: Intensive blood pressure management

Other: Systolic blood pressure target < 130 mm Hg

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

Active Comparator: Standard blood pressure management

Other: Systolic blood pressure target < 185 mm Hg

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux	Bordeaux	France
2	Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon	Lyon	France
3	Centre Hospitalier Régional Universitaire	Nancy	France
4	Hopital Lariboisière	Paris	France	75010
5	Fondation Ophtalmologique A de Rothschild	Paris	France	75019
6	Hopital Foch	Suresnes	France
7	Hopital de purpan	Toulouse	France	31 100