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OpenTrials
Completed

NCT Number: NCT03160677

Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Systolic blood pressure target < 130 mm Hg

Other

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

Systolic blood pressure target < 185 mm Hg

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study 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

Acronym: BP-TARGET

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 19, 2017
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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