Clinical trial NCT03160677: Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy
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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Blood Pressure
Cerebral Hemorrhage
Keywords: Acute Stroke
Blood Pressure
Cerebral Hemorrhage
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-05-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: Rate of patients with intracranial hemorrhagic complications
timeFrame: Scan performed between 24 and 36 hours after thrombectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lyon
country: France
facility: Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire
city: Paris
country: France
facility: Hopital Lariboisière
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: Hopital de purpan
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Mikael MAZIGHI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.