NCT05258565

Brief Summary

The investigator will recruit consecutively all patients coming with acute ischemic stroke either with or without COVID -19 infection and suitable for IV injection with Tissue plasminogen activators according to guideline and inclusion criteria of tPA. Aswan University Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

February 21, 2022

Last Update Submit

October 27, 2022

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • primary out come

    Barthel Index scale BIS (pre-post drug administration and 2 month later)The Barthel includes 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs. The original Index is a three-item ordinal rating scale completed by a therapist or other observer in 2-5 minutes. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.

    2 months

Secondary Outcomes (1)

  • secondary outcome

    2 months

Study Arms (2)

acute ischemic stroke without covid -19 infection

ACTIVE COMPARATOR

Administration of IV tPA: the dose of activase is ,9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.

Drug: IV tPA (Activase)

acute ischemic stroke associated with covid -19 infection

ACTIVE COMPARATOR

Administration of IV tPA: the dose of activase is, 9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.

Drug: IV tPA (Activase)

Interventions

IV tPA (Activase)DRUG

Any patients eligible came with acute ischemic stroke with or without COVID-19 infection within the time window for thrombolytic therapy (within 4 hours of onset)

Also known as: IV tissue plasminogen activator
acute ischemic stroke associated with covid -19 infectionacute ischemic stroke without covid -19 infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed as acute ischemic stroke NIHSS\<25
  • Symptoms onset less than 4.5 hours (3hours in diabetic or having a previous stroke) before beginning treatment.

You may not qualify if:

  • History of:
  • A previous ischemic stroke or severe head trauma in previous 3 months.
  • Previous intracranial hemorrhage .
  • Intracranial neoplasm or gastrointestinal malignancy.
  • Gastrointestinal hemorrhage in previous 3weeks.
  • Intracranial or intra spinal surgery in previous 3months
  • Clinically:
  • Symptoms suggestive of subarachnoid hemorrhage.
  • Persistent blood pressure elevation, systolic \> 185 or diastolic \>110 mmHg.
  • Active internal bleeding.
  • Presentations consistent with infective endocarditis.
  • Stroke known or suspected to be associated with aortic arch dissection.
  • Acute bleeding diathesis, including but not limited to conditions defined under hematologic.
  • Hematologic:
  • Platelet count \<100.000 \\ mm3
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aswan University Hospital

Aswān, Egypt

Location

Assiut University Hospital

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular 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 Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

February 21, 2022

First Posted

February 28, 2022

Study Start

March 1, 2022

Primary Completion

June 15, 2022

Study Completion

September 15, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

EG(2)