| CTRI Number |
CTRI/2021/11/038340 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Alteplase as a clot lysis treatment from 4.5 to 9 hours on onset in Acute Ischemic Stroke patients |
|
Scientific Title of Study
|
Bridging therapy with intravenous Alteplase in imaging eligible Acute Ischemic Stroke patients with onset between 4.5 to 9 hours - A Randomized Controlled, Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Awadh Kishor Pandit |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Neurology
Room number 703 7th Floor
Neurosciences Centre
AIIMS
New Delhi
South West
DELHI
110029
India |
| Phone |
01126594856 |
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Awadh Kishor Pandit |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Neurology
Room number 703 7th Floor
Neurosciences Centre
AIIMS
New Delhi
South West
DELHI
110029
India |
| Phone |
01126594856 |
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Awadh Kishor Pandit |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Neurology
Room number 703 7th Floor
Neurosciences Centre
AIIMS
New Delhi
South West
DELHI
110029
India |
| Phone |
01126594856 |
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences (New Delhi) |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Sri Aurobindo Marg
Ansari Nagar East
New Delhi
Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Awadh Kishor Pandit |
All India Institute Of Medical Sciences |
Room number 703,
Neuroscience Centre
Department of Neurology
South West
DELHI |
01126594856
akpandit.med@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alteplase injection |
Dosage: 0.9 mg/kg of body weight with maximum dosage of 90mg
Frequency: Once stat dose
Route of administration: Intravenous infusion
Duration: One hour of intravenous infusion |
| Comparator Agent |
Standard care |
Standard care which is already approved for management of acute ischemic stroke patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-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
|
|
| ExclusionCriteria |
| Details |
-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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The safety of Bridging therapy with intravenous Alteplase along with standard of care as
compared to standard of care alone in treatment of imaging eligible acute ischemic stroke
patients with large vessel occlusion presenting within 4.5 to 9 hours of onset. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the rate of recanalization of vessel causing stroke
|
90 days |
| 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 in who planned Mechanical Thrombectomy was not performed. |
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
treated with endovascular therapy. |
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.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |