| CTRI Number |
CTRI/2016/01/006480 [Registered on: 05/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Multicenter Trial to evaluate if Ticagrelor is effective in preventing the occurrence of heart attack, stroke and/or death due to cardiovascular events in patients who have type 2 diabetes ( THEMIS) and if so how it compares with placebo with a background of Aspirin therapy |
|
Scientific Title of Study
|
A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus
THEMIS: effect of Ticagrelor on Health outcomes in diabEtes Mellitus patients Intervention Study] |
| Trial Acronym |
THEMIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D513BC00001, Version 1.0, dated 24 October 2013 |
Protocol Number |
| NCT01991795 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prem Pais |
| Designation |
Professor of Medicine |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Head, Division of Clinical Research & Training
St. Johns Research Institute
Sarjapur Road
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
00918022065000 |
| Fax |
00918025530070 |
| Email |
pais.prem@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Tapankumar M Shah |
| Designation |
Country Head - Site Management and Monitoring - India |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
AstraZeneca Pharma India Ltd.
Block N1, 12th Floor
Manyata Embassy Business Park
Rachenahalli
Outer Ring Road
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9535104975 |
| Fax |
918067748857 |
| Email |
tapankumar.shah@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Tapankumar Shah |
| Designation |
Country Head, Clinical Operations |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
Block N1, 12th Floor,
Manyata Embassy Business park
Rachenahalli, Outer Ring Road,
Bangalore – 560045,
India
Bangalore
KARNATAKA
560045
India |
| Phone |
918067748006 |
| Fax |
|
| Email |
Tapankumar.shah@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB (Study Sponsor company)
151 85 Södertälje, Sweden |
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
151 85 Södertälje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AstraZeneca Pharma India Ltd |
Block N1, 12th Floor,
Manyata Embassy Business park
Rachenahalli, Outer Ring Road,
Bangalore – 560045,
India |
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czech Republic
Denmark
Finland
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Norway
Peru
Philippines
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Viet Nam |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suvro Banerjee |
Apollo Gleneagles Hospitals |
Kolkata, 58,
Canal Circular Road
Kolkata-700054
Kolkata
WEST BENGAL |
00919830024131
009103323201739
baners@vsnl.net |
| Dr Kannaiyan Ramamurthy |
Apollo Hospitals |
645, 646, T H Road, Tondiarpet
Chennai – 600081
Chennai
TAMIL NADU |
009104425916491
009104425911111
raghu13868@yahoo.co.in |
| Dr Asit Das |
B.M. Birla Heart Research Centre |
1/1 National Library Avenue, Kolkata-700027
Kolkata
WEST BENGAL |
00919433138144
dradascard@rediffmail.com |
| Dr Milan Chag |
Care Institute of Medical Sciences |
Plot 67/1, Opp. Panchamrut Bunglows, Nr. Shakun Mall, Off Science City Road, Sola, Ahmedabad 380060
Ahmadabad
GUJARAT |
0091791277175
00917927712770
milan.chag@cimshospital.org |
| Dr Vimal Mehta |
G.B. Pant Hospital |
Room No-133, Academic Block, 1st Floor,
Jawaharlal Nehru Marg, New Delhi- 110002
|
009101123212554
009101123212554
drvimalmehta@yahoo.co.in |
| Dr Milind Gadkari |
K.E.M. Hospital |
Department of cardiology, 5th Floor, Diamond Jubilee Building, 489, Rasta Peth, Sardar Moodliar Road,
Pune- 411011
Pune
MAHARASHTRA |
00919822030120
0002066037522
gadkaris@gmail.com |
| Dr Prachee Sathe |
Ruby Hall Clinic |
40, Sassoon Road, Pune 411001
Pune
MAHARASHTRA |
00919960686867
prachee.sathe@gmail.com |
| Dr Jitendra Pal Singh Sawhney |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg, Rajinder nagar ,
New Delhi-110060
|
009101143594466
009101142437231
jpssawhney@yahoo.com |
| Dr Prabhavathi |
Sri Jayadeva institute of Cardiovascular Sciences & Research |
Jayanagar 9th Block
Bengaluru
Karnataka
560069
Bangalore
KARNATAKA |
9845020533
08022977395
prabhavathi_in@yahoo.com |
| Dr Srilakshmi Mandayam Adhyapak |
St. Johns Medical College & Hospital |
Sarjapur Road, Koramangala
Karnataka - 560 034
Bangalore
KARNATAKA |
009108025633087
009108025630603
drkiron@hotmail.com |
| Dr KG Prakash |
Victoria Hospital |
#63/A, Ground floor, New C Block, Dept of Medicine
BMCRI, K.R. Road, Fort,
Bangalore - 560002
Bangalore
KARNATAKA |
009108026706067
009108026706067
kikkeri47@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| B.M. Birla Heart Research Centre, Institutional Ethics Committee Basment wing 1/1 National Library Avenue, Kolkata-700027, West Bengal, India |
Approved |
| Ethics Committee Apollo Hospitals, Apollo Hospitals Enterprises Ltd, 21, Greams Line, Off Greams Road, Chennai - 600006- TN |
Approved |
| Ethics Committee of Bangalore Medical College and Research institute, I Floor, Bangalore Medical College and Research institute, KR Road, Fort Bangalore - 560002 |
Approved |
| Ethics Committee of Care Institute of Medical Science, Nr. Shakun Mall, Off Science City Road, Sola, Ahmedabad 380060 |
Approved |
| Institutional Ethics Committee, Apollo Gleneagles Hospital, Kolkata, 58, Canal Circular Road, Kolkata 700054 |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, Jawharlal Nehru Marg, New Delhi-110002 |
Approved |
| KEM Hospital Research Centre, Ethics Committee, 3rd Floor, TDH Building, KEM Hospital, 489, Rasta Peth, Sardar Moodliar Road, Pune- 411011 |
Approved |
| Poona Medical Research Foundation Institutional Ethics Committee, E4C to E4F, 4th Floor, Fifth Avenue, Condominium, Dhole Patil Road, Pune 411001 |
Approved |
| Sir Ganga Ram Hospital Ethics Committee, Room # 1496, 4th Floor, Old Building, Sir Ganga Ram Hospital, Old Rejinder Nagar, New Delhi - 110060 |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
| St. Johns Medical College & Hospital Institutional Ethics Committee, Ground Floor, St. Johns Medical College, Sarjapur Road, Bangalore – 560034 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Men and women equal - greater than 50 years old with T2DM at high risk of CV events, but without a medical history of previous MI or stroke. , (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo OD |
one tablet bd given orally |
| Intervention |
Ticagrelor |
one tablet bd given orally |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
• Provision of informed consent prior to any study specific procedures
• Female or male aged equal - greater than 50 years old
• Diagnosed with Type 2 Diabetes with High Risk for Cardiovascular events with defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of equal - greater than 50% lumen stenosis of at least 1 coronary artery. |
|
| ExclusionCriteria |
| Details |
• Previous MI
• Previous Stroke
• Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy)
• Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomisation OR women who are breast-feeding |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first event included in the composite endpoint of CV death, MI or ischemic stroke |
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to Prevention of the composite of all-cause death, MI or stroke. Time to Prevention of CV death Time to Prevention of all-cause death
|
Time to Prevention of the composite of all-cause death, MI or stroke. Time to Prevention of CV death Time to Prevention of all-cause death
|
|
|
Target Sample Size
|
Total Sample Size="17000"
Sample Size from India="300"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2014 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus. Total duration of the study is up to 3.5 years. Total of 17000 subjects will be randomized globally from approximately 1000 sites from 40 countries. The primary outcome measures will be Time to first event included in the composite endpoint of CV death, MI or ischemic stroke. And secondary outcome measures will be: Time to Prevention of the composite of all-cause death, MI or stroke;, Time to Prevention of CV death , Time to Prevention of all-cause death |