Thrombolysis Outcome in Ischemic Stroke

Stroke, Acute Clinical Trial

— TOSSI  

Official title:

Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309357
• Other study ID #: 2464
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The variables of the study, including demographic characteristics, risk factors, complete drug history, nosocomial infection and other in-hospital events, hemorrhagic complications, duration of hospitalization,door to needle time, symptom to needle time, clinical and imaging characteristics of resent stroke, laboratory data including fasting blood glucose, lipid profile (total cholesterol, triglyceride, LDL, HDL), hematology markers (CBC diff, HGB, platelet), coagulation markers (PT, PTT, INR), liver function test (ALT, AST, ALP, Bill) and renal function test (BUN, Cr, Cr cl) were collected. All patients underwent a brain computed tomography scan early on the admission and after 24 hours. Cardiological evaluation including Electrocardiogram and echocardiography performed for all patients. Carotid and vertebrobasillar assessed by Doppler ultrasound or magnetic resonance angiography (MRA).

Stroke severity estimated by using modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale(NIHSS) scores on the first day of admission and at discharge by a neurology resident. Then patient evaluate every 3 months until 12 m for fallow up and in each visit vital sign, patient clinical status, any event, Barthel index was recorded.

Safety endpoints of this study were any adverse events clinically relevant to alteplase, specially hemorrhagic complications.

All patients who met all inclusion and exclusion criteria treated with 0.9 mg/kg recombinant tissue plasminogen activator (Actilyse, Boehringer Industry, Germany) up to maximum of 90 mg, 10% of which was injected as a blous dose and remainder infused over an hour.

Primary outcome of this study was alteplase effect in reduce morbidity rate defined by NIHSS and mRS score reduction and rate of functional independence at 3,6 and 12 months Barthel index in fallow up. Minimal clinically important difference defined as reduce NIHSS score at least 25% or MRS score 2 point at discharge day in comparison to admission day. In fallow up evaluations Barthel index 85-100 was considered favorable outcome. Binary outcomes included independence compared with disability or death.

Secondary outcome was rtPA therapy safety that assessed by fatal intra cranial hemorrhage. Also, mortality rate, intracranial hemorrhage rate, any hemorrhagic event rate and any adverse event rate assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. writen inform consent

2. diagnosis of acute ischemic stroke by neurologist

3. met all criteria of thrombolytic therapy

4. resived full dose of alteplase

Exclusion Criteria:

1. any contraindication of thrombolytic therapy

2. resived lower than 0.9 mg/kg alteplase

Related Conditions & MeSH terms

• Alteplase
• Mortality
• Stroke
• Stroke, Acute
• Thrombolytic Therapy

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bu Ali Sina hospital , Mazandarn University of Medical Science	Sari

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke outcome	evaluation of alteplase effect in morbidity of patient by using barthel index	3 months
Secondary	ischemic stroke mortality	mortality of patients who received alteplase	3 months
Secondary	frequency of adverse event	number of any adverse event of alteplase during study	3 months
Secondary	frequency of fatal adverse event	number of fatal adverse event of alteplase during study	3 months