NCT03160677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 21, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

May 18, 2017

Last Update Submit

August 2, 2021

Conditions

Keywords

Acute StrokeBlood PressureCerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intensive blood pressure management

EXPERIMENTAL
Other: Systolic blood pressure target < 130 mm Hg

Standard blood pressure management

ACTIVE COMPARATOR
Other: Systolic blood pressure target < 185 mm Hg

Interventions

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

Intensive blood pressure management

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

Standard blood pressure management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de Bordeaux

Bordeaux, France

Location

Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon

Lyon, France

Location

Centre Hospitalier Régional Universitaire

Nancy, France

Location

Hopital Lariboisière

Paris, 75010, France

Location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

Hopital Foch

Suresnes, France

Location

Hopital de purpan

Toulouse, 31 100, France

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

StrokeCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mikael MAZIGHI, MD PhD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 19, 2017

Study Start

June 21, 2017

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

August 3, 2021

Record last verified: 2021-08

Locations