NCT04674293

Brief Summary

Russian prospective multicenter registry study of intravenous thrombolytic therapy for acute ischemic stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

December 14, 2020

Last Update Submit

December 14, 2020

Conditions

The Aim the Study is to Collect and Analyze Data on Patients With Acute Ischemic Stroke During Intravenous Thrombolytic Therapy With Alteplase

Outcome Measures

Primary Outcomes (1)

  • The overall frequency of a favorable clinical outcome (from 0 to 2 points on the modified Rankin scale) [30 ± 7 days and 90 ± 7 days after TLT];

    3 month

Interventions

RevelisaDRUG

Thrombolytic therapy for patients with ischemic stroke

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include all patients of any gender and age with a confirmed diagnosis of ischemic stroke (AII), who meet the selection criteria for the study and are admitted to specialized hospitals. At least 500 patients are planned to be included in the study.

You may qualify if:

  • To be included in the study, patients must meet the following criteria:
  • Patients of any sex and age with a confirmed diagnosis of ischemic stroke (AII);
  • Carrying out the patient with intravenous thrombolytic therapy with the drug alteplase (Revelisa®).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal State Budgetary Institution "Federal Center for Brain and Neurotechnologies" of the Federal Medical and Biological Agency

Moscow, Ostrovityanova Street, 1, P. 10, 117997, Russia

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

January 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2022

Last Updated

December 19, 2020

Record last verified: 2020-12

Locations

RU(1)