| CTRI Number |
CTRI/2020/07/026356 [Registered on: 04/07/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The post marketing clinical research on drug Tenecteplase in patients with ST segment elevation myocardial infarction or left bundle branch block |
|
Scientific Title of Study
|
A prospective, multi-centre, phase IV study to evaluate safety and efficacy of TenecteRelTM (tenecteplase manufactured by Reliance Life Sciences Pvt. Ltd.) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| RLS/PMS/2017/01 (Version 2.0, Dated 24 Jun 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sachin Singh |
| Designation |
Head - Clinical Operations |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. (RLS) |
| Address |
Reliance Life Sciences Dhirubhai Ambani Life Sciences Centre Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai
Thane
Thane
MAHARASHTRA
400701
India |
| Phone |
02235338269 |
| Fax |
|
| Email |
Sachin2.Singh@relbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Supriya Sonowal |
| Designation |
Medical Monitor |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
9427003728 |
| Fax |
|
| Email |
Supriya.Sonowal@relbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Chaitali Bornare |
| Designation |
Project Manager |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02235338214 |
| Fax |
|
| Email |
Chaitali.Bornare@Relbio.com |
|
|
Source of Monetary or Material Support
|
| Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre,
Plot R-282 TTC Area of MIDC,
Thane Belapur Road, Rabale,
Navi Mumbai 400 701 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Jadhav |
Asian Institute of Medical Science |
Cardiology department
P-72, MilaP Nagar,
MIDC,
Dombivli(E)
Pin: 421203
Maharashtra, lndia
Thane
MAHARASHTRA |
9925035889
drnikhiljadhav@gmail.com |
| Dr Manoj Bhavarilal Chopada |
Chopda Medicare & Research Centre Pvt. Ltd |
Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute, 3/5, Patil Lane 1, Laxmi Nagar, Near KBH
Nashik
MAHARASHTRA |
9823021613
drchopdamanoj@gmail.com |
| Dr Brajesh Badhan |
Global heart and Super Speciality Hopspital |
Near Octroi, Ferozepur Road, Ludhiana - 141012
Punjab, India
Ludhiana
PUNJAB |
9814655161
bracardy2000@yahoo.co.in |
| DrSadanand Shetty |
K. J. Somaiya Hospital And Research Centre |
Department of Cardiology,
Somaiya Ayurvihar Complex,
Behind Everard Nagar,
Eastern Express Highway,
Sion – East,
Mumbai - 400022
Mumbai
MAHARASHTRA |
9821010827
DrSadanand54@gmail.com |
| Dr Sameer Ambar |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
Nehru Nagar, Belgaum – 590010, Karnataka, India
Belgaum
KARNATAKA |
9986080330
drsameerambar@rediffmail.com |
| DrVinay Krishna |
L.P.S. Institute Of Cardiology, G.S.V.M Medical College |
L.P.S. Institute Of Cardiology, G.S.V.M Medical College, Swroop Nagar, G T Road,Rawatpur, Kanpur, Uttar Pradesh
Kanpur Dehat
UTTAR PRADESH |
9336124729
vinaycvts@gmail.com |
| Dr Ajay Mahajan |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Cardiology, ICCU, 2nd Floor, Old OPD Building,Sion, Mumbai 400022
Mumbai
MAHARASHTRA |
9920432639
draumahajan@gmail.com |
| Dr Narendra Jathappa |
Nanjappa Life Care |
Nanjappa Life Care, #5619, Gadikoppa, Sagar Road,
Shivamogga-577205, Karnataka, India
Shimoga
KARNATAKA |
9448135619
jnarendra2009@gmail.com |
| Dr Sachin Hundekari |
Ojas multispeciality hospital |
Ojas Multispecialty Hospital Sr. No. 203/1 Bhondave Chowk, DY patil college road, Ravet, Pune-412101
Pune
MAHARASHTRA |
9960188184
drsachinhundekari@yahoo.com |
| Dr Mukund Kumbla |
Omega Hospitals |
Omega Hospitals, Mahaveer Circle, Kankanady,
Mangalore 575002, Karnataka, India
|
9845082811
drmukund@epsilon.net.in |
| Dr Nirav Bhalani |
Rhythm Heart Institute |
Nr Siddharth: Bunglows,
Sama- Savli Road,
Vadodara- 390022
Guiarat, India
Vadodara
GUJARAT |
91-265-2541006
trial@rhythmheart.com |
| Dr Satishkumar Kolekar |
Vedant Multispeciality Hospital |
GP 83, Opp Rotary Club, Sambhaji Nagar, MIDC, Chinchwad, Pune - 411019
Pune
MAHARASHTRA |
9619811138
drsatishkumarskolekar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee of Pulse Multispeciality Hospital |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee Deep Hospital |
Approved |
| Institutional Ethics Committee, K.J. Somaiya Medical College and Research Centre |
Submittted/Under Review |
| Institutional Ethics Committee, KLE University |
Approved |
| Institutional Ethics Committee, LTMMC and GH |
Approved |
| Magna-care ethics committee |
Approved |
| Nanjappas Institutional Ethics Committee |
Approved |
| Ojas Multispecialty Hopsital Ethics Committee |
Approved |
| Omega Ethical Committee (Omega Hospital), Mangalore- 575002 |
Approved |
| Rhythm Heart Institute Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
TenecteRelTM |
TenecteRelTM is use for in adults for thrombolytic treatment of suspected myocardial infarction with persistent ST segment elevation (STEMI) or recent left Bundle Branch Block. TenecteRelTM is for intravenous administration only as a single bolus dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ST-segment elevation ≥ 0.1 mV in two or more limb leads or > 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new onset left bundle-branch block.
2. Patients presenting with AMI within 6 hours of onset of symptoms.
3. Women of childbearing potential should have a negative pregnancy test and be taking adequate birth control measures.
4. Consent from Legally Acceptable Representative (LAR), if patient is not in the condition to give consent. However, when the patient is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study. |
|
| ExclusionCriteria |
| Details |
1. Known history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient)
2. Use of Abciximab or other marketed GPIIb/IIIa antagonists within the preceding 24 hours
3.Significant bleeding disorder either at present or within the past 6 months
4. Patients on oral anticoagulant treatment
5. Internal active bleeding or known history of hemorrhagic diathesis
6. Hypertension with systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg during current admission prior to enrolment
7. Cardiogenic shock (Systolic BP < 60 mm Hg)
8. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)
9. Recent trauma to the head or cranium within 1 year
10. Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
11. Patients with acute pericarditis and/or subacute bacterial endocarditis
12. Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
13. Patients with arterial aneurysm or known arterial/venous malformation, active peptic ulceration, acute pancreatitis, neoplasm with increased bleeding risk, or dementia
14. Known history of haemorrhagic stroke or stroke of unknown origin
15. Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months
16. Pregnancy or lactation, or parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test.
17. Known participation in another investigative drug study or investigative device protocol within the previous 3 months
18. Any other condition which investigator feels would pose a significant hazard to patient if tenecteplase is administered. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of treatment emergent adverse events occurring during the study |
Incidence of treatment emergent adverse events occurring during the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Thirty-day mortality, defined as death at or before 30 days after enrollment
-‘Net clinical benefit’ defined as the absence of mortality and non-fatal stroke at 30 days
-Incidence of stroke
-Rates of bleeding events (serious and non-serious, Major and Minor events
-Rates of bleeding events (serious and non-serious, Major and Minor events) |
30 days |
Thirty-day mortality, defined as death at or before 30 days after enrollment
-‘Net clinical benefit’ defined as the absence of mortality and non-fatal stroke at 30 days
-Incidence of stroke
-Rates of bleeding events (serious and non-serious, Major and Minor events
-Rates of bleeding events (serious and non-serious, Major and Minor events) |
30 days |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, multi-centre, phase IV study to evaluate safety and efficacy of TenecteRelTM in patients with ST segment elevation Myocardial Infarction (STEMI) or new onset left bundle branch block.
TenecteRelTM has been approved for use in adults for thrombolytic treatment of suspected myocardial infarction with persistent ST segment elevation (STEMI) or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms. |