| CTRI Number |
CTRI/2020/03/023925 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to investigate the effect of Ticagrelor sustained release tablets in patients with the history of heart attack on a background of aspirin |
|
Scientific Title of Study
|
"A Multicentric, Randomized, Open Label, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a Background of Aspirin Therapy in Patients with the History of Myocardial Infarction." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/19/003 |
Protocol Number |
| Version No. 01, Dated Sep 27, 2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Gopal Rao |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
Government Medical College and Government General Hospital (Old RIMSGGH), Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drgopalraoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
New Delhi
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India. |
| 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 Brij Mohan Goyal |
Apex Hospitals Private Limited |
Research Room, SP 4 & 6, Malviya Industrial Area, Malviya Nagar, Jaipur-302017.
Jaipur
RAJASTHAN |
9413190570
drbrijmohan.goyal@gmail.com |
| Dr Hrishikesh Bora |
Down Town Hospital |
Research Room, Dispur, G.S.Road,Guwahati-781006.
Kamrup
ASSAM |
9864044323
hris_11@yahoo.co.in |
| Dr J Naganna |
Gandhi Medical College / Hospital |
Department of General Medicine,
3rd Floor, In Patient Block, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9666345120
nagan99@gmail.com |
| Dr A Gopal Rao |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Medicine,
Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
8942279033
drgopalraoa@gmail.com |
| Dr Mahmodullah Razi |
GSVM Medical College |
Post Graduate Department of Medicine, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
7408427786
drmmrazi@gmail.com |
| Dr Sanjiv Maheshwari |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of Medicine, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Room No. 109, Basement, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9983995050
pksharma.clinical@gmail.com |
| Dr Raja Bhattacharya |
Medical College and Hospital, Kolkata |
Department of Medicine, MCH Building, 4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
9477305539
rbrbhattacharya@gmail.com |
| Dr Vikas Reddy Maddali |
Osmania Medical College & General Hospital |
Department of Cardiology,
Afzalgunj, Hyderabad-500012.
Hyderabad
TELANGANA |
9491928493
vikasreddy04@gmail.com |
| Dr Shankar Ramgouda Patil |
Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R) |
Research Room, Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali, Maharashtra-415409.
Sangli
MAHARASHTRA |
9822353411
prakashmc.research@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Centre |
Research Room, Mumbai-Goa Highway, Oshalbag,
Village-Dhargal,
Tal-Pernem, Goa-403513.
North Goa
GOA |
9158592177
redkar.research@gmail.com |
| Dr N Sandeep |
Sri Gayatri Super Speciality Hospitals |
Research Room, Durga Agraharam, Near Kotthavantenna, Vijayawada-520002.
Krishna
ANDHRA PRADESH |
9985680280
drcresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Institutional Ethics Committee for Human Research Medical College |
Approved |
| Institutional Ethics Committee, Apex Hospitals Private Limited |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMS) |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Institutional Ethics Committee, Sri Gayatri Superspeciality Hospital |
Approved |
| Prakash Medical College Institutional Ethics Committee |
Approved |
| Redkar Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ticagrelor SR Tablets 120 mg |
One tablet once a day orally in the morning every day for 168 days (24 weeks) |
| Intervention |
Ticagrelor SR Tablets 180 mg |
One tablet once a day orally in the morning every day for 168 days (24 weeks) |
| Comparator Agent |
Ticagrelor Tablets 60 mg |
One tablet twice a day orally in the morning and evening every day for 168 days (24 weeks) |
| Comparator Agent |
Ticagrelor Tablets 90 mg |
One tablet twice a day orally in the morning and evening every day for 168 days (24 weeks) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged between 40 and 75 years (both inclusive).
2. Subjects who are currently on the treatment of Ticagrelor Tablets 90 mg twice daily or 60 mg twice daily from at least 3 months with the history of myocardial infarction.
3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
4. Subjects willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.
2. Subjects who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start.
3. Subjects with history of multi vessel coronary artery disease.
4. Subjects with history of bleeding disorders.
5. Subjects who need chronic oral anti-coagulant therapy or chronic low-molecular weight heparin.
6. Subjects with a history of ischemic stroke.
7. Subjects with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years.
8. Subjects with a history of bleeding from the gastrointestinal tract (e.g., esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
9. Subjects considered to be at risk of bradycardic events unless already treated with a permanent pacemaker.
10. Subjects who have had open heart surgery within the past 5 years, unless the person had a myocardial infarction after the surgery.
11. Subjects with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
12. Subjects with kidney failure requiring dialysis.
13. Subjects with known clinically important thrombocytopenia.
14. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
15. Females who are not ready to use acceptable contraceptive methods during the course of study.
16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C.
18. Suspected inability or unwillingness to comply with the study procedures.
19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. |
At Week 1, Week 2, Week 4, Week 8, Week 12, Week 18 and Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)]. |
At Week 1, Week 2, Week 4, Week 8, Week 12, Week 18 and Week 24 |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/03/2020 |
| 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) |
Not Applicable |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
“A Multicentric, Randomized, Open Label, Parallel
Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety
and Tolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a
Background of Aspirin Therapy in Patients with the History of Myocardial
Infarction.â€
Primary objective:
To evaluate the
efficacy and safety of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a
Background of Aspirin Therapy in Patients with the History of Myocardial
Infarction.
Secondary objective:
To evaluate the
tolerability of Ticagrelor SR Tablets Versus Ticagrelor Tablets on a Background
of Aspirin Therapy in Patients with the History of Myocardial Infarction.
|