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

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ClinicalTrials.gov Identifier: NCT03160677
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : June 21, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160677


Contacts
Contact: Laurence SALOMON, MD PhD 01.48.03.64.31 ext +33 lsalomon@for.paris

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Igor SIBON         
CHU Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Christian DENIER         
Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon Not yet recruiting
Lyon, France
Contact: Francis TURJMAN         
Centre Hospitalier Régional Universitaire Recruiting
Nancy, France
Contact: Sébastien RICHARD         
Hopital Lariboisière Not yet recruiting
Paris, France, 75010
Contact: Peggy REINER         
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Mikael MAZIGHI, MD PhD       mmazighi@for.paris   
Hopital Foch Recruiting
Suresnes, France
Contact: Bertrand LAPERGUE         
Hopital de purpan Not yet recruiting
Toulouse, France, 31 100
Contact: Jean Marc OLIVOT         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Mikael MAZIGHI, MD PhD Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03160677     History of Changes
Other Study ID Numbers: MMI_2016_26
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Acute Stroke
Blood Pressure
Cerebral Hemorrhage

Additional relevant MeSH terms:
Stroke
Hemorrhage
Cerebral Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages