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

August 2, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Lyon, France
        • Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon
      • Nancy, France
        • Centre hospitalier régional universitaire
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75019
        • Fondation Ophtalmologique A de Rothschild
      • Suresnes, France
        • Hopital Foch
      • Toulouse, France, 31 100
        • Hôpital de Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with intracranial hemorrhagic complications
Time Frame: 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
Scan performed between 24 and 36 hours after thrombectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Mikael MAZIGHI, MD PhD, Fondation Ophtalmologique A. de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (ACTUAL)

May 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMI_2016_26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on Systolic blood pressure target < 130 mm Hg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe