NCT05517109

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

August 6, 2022

Last Update Submit

October 28, 2024

Conditions

Acute Ischemic StrokeIntracranial Hemorrhage

Outcome Measures

Primary Outcomes (4)

  • Modified Rankin Scale score

    Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome.

    90 day after intravenous thrombolysis

  • Mortality rate

    At 90 day after intravenous thrombolysis

  • Rate of symptomatic intracranial hemorrhage

    Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

    24 hours after intravenous thrombolysis

  • Rate of symptomatic intracranial hemorrhage

    Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

    7 days after intravenous thrombolysis

Secondary Outcomes (6)

  • Change in National Institutes of Health Stroke Scale (NIHSS)

    at 28 day after intravenous thrombolysis

  • Rate of all Intracranial hemorrhage

    24 hours after intravenous thrombolysis

  • Rate of all Intracranial hemorrhage

    7 days after intravenous thrombolysis

  • Lengths of stay in ICU

    at 90 day after intravenous thrombolysis

  • Lengths of stay in hospital

    at 90 day after intravenous thrombolysis

  • +1 more secondary outcomes

Study Arms (2)

Control group. Standart care

NO INTERVENTION

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

Systolic blood pressure ≤ 160 mmHg

EXPERIMENTAL

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

Other: Hemodynamic goal including lower goal of systolic blood pressure

Interventions

Hemodynamic goal including lower goal of systolic blood pressureOTHER

Different hemodynamic goals in different study arms

Systolic blood pressure ≤ 160 mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Arkhangelsk, 163000, Russia

Location

MeSH Terms

Conditions

Ischemic StrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mikhail Kirov, PhD

    Northen state medical university

    STUDY DIRECTOR

  • Alexey Avidzba

    Northen state medical university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 26, 2022

Study Start

March 12, 2022

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)