NCT04309357

Brief Summary

Consecutive patients with diagnosis of acute ischemic stroke and candidate of thrombolytic therapy during Jan 2017-Mar 2019 in BuAli Sina Hospital ,Sari, Iran, enrolled to this cohort study. The demographic data, stroke characteristis, lab data and ... recorded. Then patients evaluate every 3 month until 12 month for fallow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

January 1, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

March 12, 2020

Last Update Submit

July 8, 2020

Conditions

Stroke, AcuteThrombolytic TherapyAlteplaseMortality

Outcome Measures

Primary Outcomes (1)

  • Ischemic stroke outcome

    evaluation of alteplase effect in morbidity of patient by using barthel index

    3 months

Secondary Outcomes (3)

  • ischemic stroke mortality

    3 months

  • frequency of adverse event

    3 months

  • frequency of fatal adverse event

    3 months

Interventions

AlteplaseDRUG

Alteplase in dose 0.9 mg/kg in acute ischemic patient with indications of thrombolytic therapy

Also known as: recombinant tissue plasminogen activator

Eligibility Criteria

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

All consecutive patient with diagnosis of acute ischemic stroke that met all criteria of thrombolytic therapy, that reffered to Bu Ali Sina hospital during jan 2017-mar 2019, enrolled to this study

You may qualify if:

  • writen inform consent
  • diagnosis of acute ischemic stroke by neurologist
  • met all criteria of thrombolytic therapy
  • resived full dose of alteplase

You may not qualify if:

  • any contraindication of thrombolytic therapy
  • resived lower than 0.9 mg/kg alteplase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bu Ali Sina hospital , Mazandarn University of Medical Science

Sari, Iran

Location

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Sharifi-Razavi

    Mazandaran University of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in neurology

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

January 1, 2017

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

IR(1)