CTRI

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CTRI Number

CTRI/2009/091/000251 [Registered on: 24/06/2009]

Last Modified On:

29/12/2017

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug
Biological

Study Design

Single Arm Study

Public Title of Study
Modification(s)

Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke

Scientific Title of Study
Modification(s)

Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
GBL/TNK-TPA/AIS/002	Protocol Number
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name	Dr Sandeep Sonawane
Designation	Manager
Affiliation
Address	Emcure Pharmaceuticals Ltd. 255/2 Hinjwadi, Phase-I Pune Pune MAHARASHTRA 411057 India
Phone
Fax
Email	sandeep.sonawane@emcure.co.in

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Sandeep Sonawane
Designation
Affiliation
Address	Emcure Pharmaceuticals Ltd 255/2, Phase I, Hinjwadi Pune MAHARASHTRA 411057 India
Phone	020-39821000
Fax	020-39821019
Email	Sandeep.Sonawane@emcure.co.in

Details of Contact Person
Public Query
Modification(s)

Name	Dr Sandeep Sonawane
Designation
Affiliation
Address	Manager- Medical, Emcure Pharmaceuticals Ltd 255/2, Phase I, ITBT PArk, Hinjwadi Pune MAHARASHTRA 411057 India
Phone	020-39821000
Fax	020-39821019
Email	Sandeep.Sonawane@emcure.co.in

Source of Monetary or Material Support
Modification(s)

Gennova Biopharmaceuticals Limited, Pune

Primary Sponsor
Modification(s)

Name	Gennova Biopharmaceuticals Limited Pune
Address	Hinjwadi, Pune
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor
Modification(s)

Name

Address

Countries of Recruitment
Modification(s)

India

Sites of Study
Modification(s)

No of Sites = 17
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr. K. Abdul Salam	Baby Memorial Hospital	I G Road,-673 004
Dr. Deepak Namjoshi	Criticare Hospital	,-m Mumbai MAHARASHTRA	drasv@rediffmail.com
Dr. K. K. Nirmal Raj	Dhanalakshmi Hospital	,-670002 Kannur KERALA
Dr B. Raghunath	Elite Hospital	P.B.No.1414, P.O.Koorkenchery,-680007 Thrissur KERALA
Dr. Barmare Shahid	Kurza Nursing Home	,- Mumbai MAHARASHTRA
Dr. Deepak Sitaram Laddhed	Laddhed Hospital	Wankhede layout,-422001
Dr. R. Srinivasa	M.S. Ramaiah Memorial Hospital	Bangalore,-560 054 Bangalore KARNATAKA
Dr. Shankara Nellikunja	Mallikatta Neurocentre	Opp. Mallikatta Circle, Kadri, mallikatta,-575002 Bangalore KARNATAKA
Dr. P.H.A. Majeed	Mother Hospital Pvt Ltd	Olari,-680012 Thrissur KERALA
Dr. Indraneel Basu	Popular Hospital	Kakarmatta,-221109 Varanasi UTTAR PRADESH
Dr. Shirish D Deshpande	Rajebahadar Hospital and research center Pvt Ltd	13-14/199, Rajebahadar, Tilak road,-422001 Nashik MAHARASHTRA
Dr. R. S. Wadia	Ruby Hall Clinic	,- Pune MAHARASHTRA	pmrf@giaspn01.vsnl.net.in
Dr. Vijay Dhonge	Shreeji Multipeciality hospital and clinical research center	Castle Rock, near Canada corner signal, Opp. Vishwas Bank,-422005 Nashik MAHARASHTRA
Dr. K.Asokan	Sri Ramakrishna Hospital	No 395, Avarampalayam Road ,Sarojini Naidu Road, Sidhapudur-641044 Coimbatore TAMIL NADU
Dr.Vikram Sharma	St.Theresa's Hospital	Erragadda, Sanath Nagar,-500018 Hyderabad ANDHRA PRADESH
Dr. Zubin Vaid	UNIQUE Hospital and polyclinic	, Jamuna appt, 1st Floor, S.V. Road,Andheri (W)-400056 Mumbai MAHARASHTRA
Dr. M Pradeep	WELCARE Hospital	Pirayari Junction,-679312 Palakkad KERALA

Details of Ethics Committee

No of Ethics Committees= 17
Name of Committee	Approval Status
BABY Memorial Hospital Ethics committee for Dr. K. Abdul Salam	Approved
Ethics Committee, ST. THERESA?S Hospital for Dr. Vikram Sharma	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. B. Raghunath	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Deepak S. Laddhed	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Indraneel Basu	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. K. Asokan	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. K.K.Nirmal Raj	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. M. Pradeep	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. P.H.A. Abdul Majeed	Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Shirish Deshpande	Approved
Kotbagi Hospital- Independant Ethics Committee for Dr. Deepak Namjoshi	Approved
Kotbagi Hospital- Independant Ethics Committee for Dr. Shahid Barmare	Approved
Kotbagi Hospital- Independant Ethics Committee for Dr. Zubin Vaid	Approved
M.S.Ramaiah Medical college and Teaching Hospital Ethical Review Board For Dr. R. Srinivasa	Approved
Mallikatta Ethics committee for Dr. Shankara Nellikunja	Approved
Poona Medical Research Foundation for Dr R.S. Wadia	Approved
SMIRC - EC for Dr. Vijay Dhondge	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Acute Ischemic Stroke,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	Tenecteplase (TNK-TPA)	Injection Tenecteplase (TNK-TPA)0.1 or 0.2 mg/kg IV bolus

Inclusion Criteria
Modification(s)

Age From	18.00 Day(s)
Age To	75.00 Year(s)
Gender	Both
Details	1. Ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) 2. Treatment within 3 hours of stroke onset 3. Age 18 to 75 years 4. Patient or legally acceptable representative willing to give informed consent before study procedure

ExclusionCriteria

Details

1. Minor stroke symptoms or major symptoms rapidly improving
2. Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
3. Clinical presentation suggesting subarachnoid haemorrhage
4. Pregnancy
5. Known bleeding diathesis and/or platelet count < 100 000 mm3
6. Patient taking oral anticoagulants.
7. Patients who have received heparin within 48 hours
8. Major surgery or serious trauma within 14 days; serious head trauma within 3 months
9. Gastrointestinal or urinary tract hemorrhage within 21 days
10. Arterial puncture at a noncompressible site or lumbar puncture within 7 days
11. Uncontrolled baseline hypertension ( >185/110 mm Hg)
12. Clinical stroke within 3 months or history of intracranial hemorrhage
13. Myocardial infraction in past 30 days
14. Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness
15. Seizure at stroke onset
16. Confounding pre-existent neurological or psychiatric disease
17. Any other investigational drug within 14 days
18. Large areas (greater than one lobe) of obvious low density on baseline head CT scan
19. Unlikely to complete the protocol follow-up
20. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.

Method of Generating Random Sequence
Modification(s)

Not Applicable

Method of Concealment
Modification(s)

An Open list of random numbers

Blinding/Masking
Modification(s)

Open Label

Primary Outcome
Modification(s)

Outcome	TimePoints
Neurological improvement at 24 hours as indicated by neurological improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale	0 and 24 hours

Secondary Outcome
Modification(s)

Outcome	TimePoints
Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and 3 months	0, 7, 30 and 90 days

Target Sample Size
Modification(s)

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial
Modification(s)

Phase 2/ Phase 3

Date of First Enrollment (India)
Modification(s)

25/06/2009

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial
Modification(s)

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

The objective of the present study is to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in the treatment of acute ischemic stroke at the doses of 0.1 mg/kg and 0.2 mg/kg. This will be an open label, randomized, multi-centric clinical trial conducted in 50 patients at neurology centers across India. Patients with acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) within 3 hours of onset, aged 18-75 years will be enrolled. Patients recovering from stroke, with any bleeding disorder, on anticoagulant therapy, with uncontrolled hypertension, myocardial infarction, seizures, pre-existing neurological or psychiatric disease and pregnant patients will be excluded from the study. Patients will be randomized to receive either the dose of 0.1 mg/kg or 0.2 mg/kg. Tenecteplase will be administered as an IV bolus over 5-10 seconds within 3 hours of onset of stroke. The primary efficacy variable will be neurological improvement at 24 hours as indicated by neurological improvement of â‰¥ 8 point or a score of 0 on the NIH Stroke scale. This will be expressed as percentage of responders and will be compared. The secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale, Barthel index, modified Rankin scale and Glasgow Outcome scale measured at 7 days, 1 month and 3 months. The safety variables will be percentage of patients suffering from symptomatic intracranial hemorrhage within 36 hours of treatment and percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment. The safety variables will be analyzed using percentages and proportions. For all statistical tests a p-value of â‰¤ 0.05 will be considered as significant.