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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Cerebral Hemorrhage; Acute Stroke; Blood Pressure

Treatments: Other: Systolic blood pressure target < 130 mm Hg; Other: Systolic blood pressure target < 185 mm Hg

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03160677

MMI_2016_26

Details and patient eligibility

About

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.

Full 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

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

320 participants in 2 patient groups

Intensive blood pressure management

Experimental group

Treatment:

Other: Systolic blood pressure target < 130 mm Hg

Standard blood pressure management

Active Comparator group

Treatment:

Other: Systolic blood pressure target < 185 mm Hg