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

NCT ID: NCT05517109

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-12

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke Intracranial Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group. Standart care

Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis

Group Type NO_INTERVENTION

No interventions assigned to this group

Systolic blood pressure ≤ 160 mmHg

Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis

Group Type EXPERIMENTAL

Hemodynamic goal including lower goal of systolic blood pressure

Intervention Type OTHER

Different hemodynamic goals in different study arms

Interventions

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Hemodynamic goal including lower goal of systolic blood pressure

Different hemodynamic goals in different study arms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikhail Kirov, PhD

Role: STUDY_DIRECTOR

Northen state medical university

Alexey Avidzba

Role: STUDY_CHAIR

Northen state medical university

Locations

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City Hospital # 1 n.a. E.E. Volosevich

Arkhangelsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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IVT-160

Identifier Type: -

Identifier Source: org_study_id

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