Using Alteplase as a clot lysis treatment from 4.5 to 9 hours on onset in Acute Ischemic Stroke patients

Not yet recruiting

Conditions: Diseases of the nervous system,

Registration Number: CTRI/2021/11/038340

Lead Sponsor: All India Institute Of Medical Sciences

Brief Summary: Stroke is second major cause of disability and third most common cause of mortality in India. The crude prevalence of stroke in India ranges from 44.29-559/lakh person and incidence 105-152/lakh person over last 20 years. Rate of thrombolysis within 4.5 hours of Acute Ischemic Stroke (AIS) onset is 5%-12% worldwide including India. Difficult areas in India are: Reaching hospital within window period, wake-up stroke, remembering the onset time of stroke and also affordability of therapy. Intravenous (IV) Thrombolysis with alteplase, a human tissue plasminogen activator (tPA), is the standard of care prior to mechanical thrombectomy (MT) for eligible patients with acute ischemic stroke AIS within 4.5 hours. Hence, considering a very low rate of thrombolysis worldwide including India, this trial will give an opportunity to bring a proof of concept for future phase III RCT and encourage bridging with Alteplase by the time patient reaches hospital and is able to undergo MT, even in patients reaching at delayed window or atleast receives thrombolysis safely and leading to improved functional outcome. We aim to test the hypothesis by conducting a randomised controlled, pilot study to evaluate the safety of injection Alteplase.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Age > 18 years -Acute Ischemic Stroke symptom onset within past 4.5-9 hours -Acute Ischemic Stroke consistent within ICA, MCA or ACA territory -Baseline mRS 0-2 -NIHSS score of >5 at baseline and prior to randomization -Imaging eligibility with perfusion lesion ischemic core mismatch greater than 1.8 between the volume of hypoperfusion and volume of the ischemic core, an absolute difference in volume greater than 10 ml, and an ischemic-core volume of less than 70 ml.

Exclusion Criteria

Imaging shows more than 1/3 of MCA territory infarct or more than one vascular territory -Acute or previous intracranial hemorrhage -Active internal organ bleeding.
Known hypersensitivity to Alteplase.
Seizures at stroke onset -Severe, uncontrolled hypertension.
Treatment with a thrombolytic within last 3 months -Prior ischemic stroke, severe head trauma, intracranial/intraspinal injury within 3 months -Gastrointestinal malignancy or GI bleed within 21 days -Occlusion in > 1 vascular territory.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compared to standard of care alone in treatment of imaging eligible acute ischemic stroke	90 days
1. The safety of Bridging therapy with intravenous Alteplase along with standard of care as	90 days
patients with large vessel occlusion presenting within 4.5 to 9 hours of onset.	90 days

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in who planned Mechanical Thrombectomy was not performed.	90 days
Proportion of patients with a Barthel Index score of 95	90 days
Proportion of patients with good recovery based on the Glasgow Outcome Scale	90 days
Proportion of patients with reperfusion at 24 hours post randomization, define as a more than 90% reduction in time to maximum more than 6 seconds lesion volume.
To determine the rate of recanalization of vessel causing stroke
To determine the rate of reduction of need of decompressive hemicraniectomy in cases of large vessels obstruction.	90 days
Proportion of patients with functional independence, define as mRS of 0 to 2	90 days
Proportion of patients with angiography reperfusion (treatment in cerebral ischemia	{TICI} 2b/3 or TICI 3) at completion of angiography procedure (only for patients

Trial Locations

Locations (1): All India Institute Of Medical Sciences
🇮🇳
West, DELHI, India
All India Institute Of Medical Sciences
🇮🇳West, DELHI, India
Dr Awadh Kishor Pandit
Principal investigator
01126594856
akpandit.med@gmail.com