Clinical trial NCT05258565: TPA in Acute Stroke With COVID Verus Non-COVID-19 Patients
Official title: Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2022-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: primary out come
timeFrame: 2 months
Secondary outcomes:
measure: secondary outcome
timeFrame: 2 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References: