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Acute Ischemic StrokePhase 1rTPANCT05258565

TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients

A Phase 1 study testing IV tPA (Activase) in people with Acute Ischemic Stroke, run by Assiut University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
IV tPA (Activase)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesEgypt
Study dates
1 Mar 2022to 15 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Aswan University Hospital

    Aswān

  • Assiut University Hospital

    Asyut

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
IV tPA (Activase)
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IV tPA (Activase)Drug

    Also called IV tissue plasminogen activator

    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)

Study groups in NCT05258565
Study groupRoleWhat they receive
acute ischemic stroke without covid -19 infectionActive comparatorAdministration of IV tPA: the dose of activase is ,9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.
Receives: Drug: IV tPA (Activase)
acute ischemic stroke associated with covid -19 infectionActive comparatorAdministration of IV tPA: the dose of activase is, 9 mg /kg (not exceeding 90 mg total treatment dose) Infused over 90 minutes.
Receives: Drug: IV tPA (Activase)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Secondary outcomes (1)

  1. secondary outcome

    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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion15 Jun 2022
  4. Study completion15 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258565
Sponsor's protocol ID
TPA in acute stroke
Acronym
rTPA
Status last verified
Oct 2022
First submitted
21 Feb 2022
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IV tPA (Activase) in people with Acute Ischemic Stroke, run by Assiut University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary out come (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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