TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients (rTPA)

October 27, 2022 updated by: Eman M. Khedr, Assiut University

Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute ischemic stroke (AIS) is a time sensitive medical emergency and a leading cause of morbidity and mortality worldwide. Intravenous (IV) recombinant tissue plasminogen activator (IV alteplase) is currently the only proven effective medication for the treatment of AIS with promising adjuvant medications currently under investigation.(Gottula et al, 2021).

Intravenous tissue plasminogen activator (tPA) is used to treat acute stroke because of its thrombolytic activity and its ability to restore circulation to the brain. (Wang, et. al, 1998). However tPA administration, especially delayed administration is associated with increased intracranial hemorrhage, hemorrhagic transformation and mortality. (Jong, 2019) Acute cerebrovascular disease, particularly ischemic stroke, has emerged as a serious complication of infection by the severe acute respiratory syndrome coronavirus that caused by the Coronavirus disease-2019 (COVID-19). Such specificities include a propensity towards large vessel occlusion, multi-territory stroke, and involvement of otherwise uncommonly affected vessels. The pathogenesis and optimal management of ischemic stroke associated with COVID-19 still remain uncertain, but emerging evidence suggest that cytokine storm-triggered coagulopathy and endotheliopathy represent possible targetable mechanisms. (Vogrig, et. al, 2021).

Anew study was done in United States in 2020, included 13 patients presented with acute ischemic stroke and systemic symptoms consistent with covid-19 were treated with IV tPA. 61.5% of patients improved at follow up, Neither of them complicated with systemic or symptomatic intracranial hemorrhages.(Carneiro, et. al, 2020). IV tPA may be safe and efficacious in COVID -19 but larger studies are needed to validate these results (Carneiro, et. al, 2020).

The purpose of this study is to compare between the safety and efficacy of tPA management of ischemic stroke in Covid-19 and non covid-19 patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital
      • Aswan, Egypt
        • Aswan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Current anticoagulant use with INR>1.7 or PT>15sec or PTT> 40sec.
  • Therapeutic doses of low molecular weight received in 24 hours (not include the prophylactic doses).

Head CT:

  • Evidence of hemorrhage.
  • Extensive regions of obvious hypo density

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: acute ischemic stroke without covid -19 infection
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)
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)
Other Names:
  • IV tissue plasminogen activator
Active Comparator: acute ischemic stroke associated with covid -19 infection
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)
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)
Other Names:
  • IV tissue plasminogen activator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary out come
Time Frame: 2 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary outcome
Time Frame: 2 months

NIHSS (pre-post drug administration and 2 month later a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items( Level of Consciousness ,Horizontal Eye Movement, Visual field test, Facial Palsy, Motor Arm, Motor Leg, Limb Ataxia ,Sensory, Language and Speech)

, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.Score 0 means No stroke symptoms. score 1-4 means Minor stroke .Score 5-15 means Moderate stroke. score 16-20 means Moderate to severe stroke. Score 21-42 means Severe stroke
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Aswan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPA in acute stroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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