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

Primary Purpose

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systolic blood pressure target < 130 mm Hg
Systolic blood pressure target < 185 mm Hg
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Stroke focused on measuring Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHU de Bordeaux
  • Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon
  • Centre Hospitalier Régional Universitaire
  • Hopital Lariboisière
  • Fondation Ophtalmologique A de Rothschild
  • Hopital Foch
  • Hopital de purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive blood pressure management

Standard blood pressure management

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 18, 2017
Last Updated
August 2, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT03160677
Brief Title
Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, Blood Pressure, Cerebral Hemorrhage
Keywords
Acute Stroke, Blood Pressure, Cerebral Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive blood pressure management
Arm Type
Experimental
Arm Title
Standard blood pressure management
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Systolic blood pressure target < 130 mm Hg
Intervention Description
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg
Intervention Type
Other
Intervention Name(s)
Systolic blood pressure target < 185 mm Hg
Intervention Description
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg
Primary Outcome Measure Information:
Title
Rate of patients with intracranial hemorrhagic complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael MAZIGHI, MD PhD
Organizational Affiliation
Fondation Ophtalmologique A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Centre Hospitalier Régional Universitaire
City
Nancy
Country
France
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Fondation Ophtalmologique A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hopital Foch
City
Suresnes
Country
France
Facility Name
Hopital de purpan
City
Toulouse
ZIP/Postal Code
31 100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36041869
Citation
Maier B, Brauner R, Escalard S, Gory B, Lapergue B, Sibon I, Richard S, Labreuche J, Kyheng M, Desilles JP, Blanc R, Piotin M, Halimi JM, Mazighi M; BP-TARGET Trial Investigators. Association of Contrast Enhancement After Reperfusion With Outcomes According to Blood Pressure Lowering in Patients With Acute Ischemic Stroke. Neurology. 2022 Nov 22;99(21):e2385-e2394. doi: 10.1212/WNL.0000000000201173. Epub 2022 Aug 30.
Results Reference
derived
PubMed Identifier
35321558
Citation
Maier B, Gory B, Lapergue B, Sibon I, Richard S, Kyheng M, Labreuche J, Desilles JP, Blanc R, Piotin M, Mazighi M, Halimi JM; BP TARGET Investigators. Effect of Baseline Antihypertensive Treatments on Stroke Severity and Outcomes in the BP TARGET Trial. Stroke. 2022 Jun;53(6):1837-1846. doi: 10.1161/STROKEAHA.121.037548. Epub 2022 Mar 24.
Results Reference
derived
PubMed Identifier
35109685
Citation
Anadani M, Maier B, Escalard S, Labreuche J, de Havenon A, Sabben C, Lapergue B, Gory B, Richard S, Sibon I, Desilles JP, Blanc R, Piotin M, Mazighi M; of behalf the BP-TARGET Study Group*. Magnitude of Blood Pressure Change After Endovascular Therapy and Outcomes: Insight From the BP-TARGET Trial. Stroke. 2022 Mar;53(3):719-727. doi: 10.1161/STROKEAHA.121.036701. Epub 2022 Feb 3.
Results Reference
derived
PubMed Identifier
33647246
Citation
Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hebert S, Maier B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.
Results Reference
derived

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

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