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Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients

N

Northern State Medical University

Status

Completed

Conditions

Intracranial Hemorrhage
Acute Ischemic Stroke

Treatments

Other: Hemodynamic goal including lower goal of systolic blood pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05517109
IVT-160

Details and patient eligibility

About

The investigators are suggtesting that lower goals of systolic blood pressure after intravenous thrombolysis may reduce the risk of hemorrhagic complications and improve functional outcomes after acute ischemic stroke.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion сriteria:

  • ischemic stroke diagnosis
  • performed intravenous thrombolysis (including "wake up stroke")
  • systolic blood pressure >140 mmHg
  • informed consent or council of physician agreement

Exclusion criteria:

  • absence of informed consent or council of physician agreement
  • pregnancy
  • patients participainting in other clinical trial in the last 90 days
  • any absolute contraindications to intravenous thrombolysis

Сompletion criteria:

  • failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis
  • failure to achieve hemodynamic goal for 60 minutes in first 24 hours after intravenous thrombolysis
  • relative arterial hypotension (SBP <100 mmHg for 60 minutes in first 24 hours after intravenous thrombolysis)
  • unfavorable effect development (e.g. seizures, angioedema)
  • informed consent is retracted

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Control group. Standart care
No Intervention group
Description:
Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis
Systolic blood pressure ≤ 160 mmHg
Experimental group
Description:
Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis
Treatment:
Other: Hemodynamic goal including lower goal of systolic blood pressure

Trial contacts and locations

1

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Central trial contact

Alexey Avidzba

Data sourced from clinicaltrials.gov

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