Clinical trial NCT04309357: Thrombolysis Outcome in Ischemic Stroke
Official title: Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Thrombolytic Therapy
Alteplase
Mortality
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patient with diagnosis of acute ischemic stroke that met all criteria of thrombolytic therapy, that reffered to Bu Ali Sina hospital during jan 2017-mar 2019, enrolled to this study

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ischemic stroke outcome
timeFrame: 3 months
Secondary outcomes:
measure: ischemic stroke mortality
timeFrame: 3 months
measure: frequency of adverse event
timeFrame: 3 months
measure: frequency of fatal adverse event
timeFrame: 3 months
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Bu Ali Sina hospital , Mazandarn University of Medical Science
Study officials:
affiliation: Mazandaran University of Medical Science
name: Sharifi-Razavi
role: PRINCIPAL_INVESTIGATOR
References: