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1 Clinical Trial Details (PDF Generation Date :- Thu, 07 Mar :24:40 GMT) CTRI Number Last Modified On 27/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/07/ [Registered on: 13/07/2016] - Trial Registered Prospectively PMS Drug Randomized, Parallel Group, Placebo Controlled Trial TWILIGHT Study The anti platelet therapy with both ticagrelor and aspirin for 3 months after coronary intervention followed by ticagrelor only for a year rather than both aspirin and ticagrelor is better in reducing the ischemic events in high risk patients. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) ISSBRIL0345,Version 3.1 dated 7-Aug-2015 Designation Affiliation DCGI Details of Principal Investigator DrUpendra Kaul Phone Fax Designation Affiliation Executive director-academics Research,Fortis Escort Heat Insititute Fortis Escort Heart Institute,Okhla,New delhi Fortis Escort Heart Institute Okhla, Fortis Escort Heart Institute Okhla, upendra.kaul@fortishealthcare.com Details Contact Person (Scientific Query) Dr Upendra Kaul Phone Fax Designation Affiliation Executive director-academics Research,Fortis Escort Heat Insititute Fortis Escort Heart Institute,Okhla,New delhi Fortis Escorts Heart Institute Okhla, Fortis Escorts Heart Institute Okhla, upendra.kaul@fortishealthcare.com Details Contact Person (Public Query) Dr Upendra Kaul Executive director-academics Research,Fortis Escort Heat Insititute Fortis Escort Heart Institute,Okhla,New delhi fortis escort heart institute,okhla fortis escort heart institute,okhla page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Astra zeneca Type of Sponsor List of Countries Brazil Bulgaria Canada Denmark Egypt France Hungary Israel Italy New Zealand Poland South Africa United Kingdom United States of America of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI icahn school of medicine at amount sinai, one Gustave,L.Levy place,box 1234, New york NY Research institution and hospital dr Neera Pandit Dr.Ram Manohar Lohia Hospital Dr Neeraj parakh of Site Site Phone/Fax/ All Institute of Dr.Ram Manohar Lohia Hospital Department of cardiology Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place,, All Institute of cardiology,gautam Nagar, Ansari Nagar East,, Delhi om om drsatya Gupta Care Institute of Care Institute of page 2 / 7

3 Details of Ethics Committee Dr Gurpreet Singh Wander Dr Sanjeev K Sharma Dr Arun Kumar Chopra Dayanand Medical College and hospitals,hero DMC Eternal Heart Care Centre and Research centre cardiology,nr. Shukan Mall, Off Science City Road, Sola, Ahmedabad Ahmadabad GUJARAT ayanand Medical College and hospitals,hero DMC,Tagore road civil lines,tagore nagar Ludhiana PUNJAB Eternal Heart Care and Research Centre cardiology,3a jagatpura road,near jawahar circle,jaipur Jaipur RAJASTHAN Fortis Hopitals Amritsar Fortis Escorts Hospitals Majitha Verka Bypass Road Amritsar PUNJAB Dr Keshava Fortis Hospital Cunningham Road Sheriff s Chamber Bangalore Bangalore KARNATAKA Dr Parneesh Arora Fortis Hospitals Fortis Hospital B-22, Sector-62 ida dr Milind Gadkari Dr Prabhavathi KEM Hospital Research Centre Sri Jayadeva Institute of Cardiovascular Sciences and Research KEM Hospital Research Centre cardiology,sardar moodliar road,rasta peth,pune Pune MAHARASHTRA sri jayadeva institute of cardiovascular sciences and research cardiology,bannerghatta Road, Jayanagar 9th Block, Bangalore Bangalore KARNATAKA satya.gupta@cims.me drgswander@yahoo.co m sanzsharma@gmail.co m akchopra1@rediffmail.c om rkeshava@hotmail.com parneesh.arora@fortish ealthcare.com gadkaris@gmail.com prabhavathi_in@yahoo. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? All Institute of Date Specified page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Care Institute of Dayanand Medical College and hospital,hero DMC Dr.Ram Manohar Lohia Hospital Eternal Heart care centre Ethics Committee Apex Heart Institute Ethics committee for Research Approved 09/11/2015 Institutional Ethics Comittee Fortis Hospital ida Institutional Ethics Commitee Amiritsar Institutional Ethics Committe,Fortis Escort Heart Institute Institutional Ethics Committee Fortis Hospital Bangalore Date Specified Date Specified Approved 09/11/2015 Approved 13/08/2016 Approved 06/05/2016 Date Specified Date Specified t Available Approved 14/06/2016 Date Specified KEM Research Hospital Approved 16/11/2015 Sri jayadeva institute of Approved 30/10/2015 cardiovascular sciences Status Date Approved/Obtained 29/06/2016 Health Type Patients Condition Patients with acute coronary syndrome and undergone PCI with one drug eluting stent Type Details Intervention Aspirin is the study drug and ticagrelor is a open label study drug. There are two arms both will receive ticagrelor and one would receive Aspirin and the other the aspirin placebo,aspirin 81 mg,daily,orally for 12 months and ticagrelor-90 mg,twice daily for 12 months Comparator Agent Aspirin placebo aspirin placebo would be given to one of the arms as per electronic allocation Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Clinical Inclusion Criteria (MUST MEET AT LEAST ONE): 1. Adult patients? 65 years of age 2. Female gender 3.Troponin positive acute coronary syndrome 4. Established vascular disease defined as previous MI, documented page 4 / 7

5 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Pre-numbered or coded identical Containers Participant and Investigator Blinded PAD or CAD/PAD revascularization 5. Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin) 6. Chronic kidney disease defined as an estimated glomerular filtration rate (egfr) Angiographic Inclusion Criteria (MUST MEET AT LEAST ONE): 7. Multivessel coronary artery disease 8.Target lesion requiring total stent length >30 mm 9.Thrombotic target lesion(s) 10.Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents 11. Left main (?50%) or proximal LAD (?70%) lesion 12. Calcified target lesion(s) requiring atherectomy Exclusion Criteria Exclusion Criteria: 1.Under 18 years of age 2.Contraindication to aspirin 3. Contraindication to ticagrelor 4. Planned surgery within 90 days 5. Planned coronary revascularization (surgical or percutaneous) within 90 days 6.Need for chronic oral anticoagulation 7.Prior stroke 8.Dialysis-dependent renal failure 9.Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding) 10.Salvage PCI or STEMI presentation. 11.Liver cirrhosis 12.Life expectancy 13.Unable or unwilling to provide informed consent 14.Women of child bearing potential (as determined by hospital standard of care) Fibrinolytic therapy within 24 hours of index PCI 15. Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 16.Platelet count 17.Requiring ongoing treatment with aspirin? 325 mg daily Primary Outcome Outcome Timepoints The primary bleeding endpoint of the present 12 months study is the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding. The primary ischemic endpoint of the present study is the time to first occurrence of confirmed all-cause death, non-fatal myocardial infarction, or stroke. Secondary Outcome Outcome Timepoints Ischemic episode [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] the time to first occurrence of confirmed cardiovascular death, non-fatal myocardial 12 months page 5 / 7

6 Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary infarction, ischemic stroke or ischemia-driven revascularization Total Sample Size=9000 Sample Size from = /08/ /07/2015 Years=1 Months=6 Days=0 Open to Recruitment Open to Recruitment Purpose: The purpose of this study is to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding among high-risk patients who have had a percutaneous coronary intervention with at least one drug- eluting stent. Ticagrelor and aspirin are both drugs used to prevent blood clots. They stop platelets (your blood s clotting cells) from sticking together and forming a blood clot that could block blood flow to the heart. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria. Patient may qualify to take part in this research study because you have one or more of the conditions above and you have undergone a Percutaneous coronary intervention (PCI) to open a blocked artery in the heart, and your physician has prescribed low dose aspirin and a specific antiplatelet medication called ticagrelor as part of your standard of care treatment. The bleeding and ischemic events are studied for 18 months At 30 days after enrollment, you will be contacted (by phone or mail) by a member of the research team to see how you are doing. If you no longer meet criteria for inclusion in the study, you will complete your study related activities at this time and will not need to return for any in-person visits or be further contacted by the research team. The research team may, however, obtain information from medical or public records, about your vital status (for example, whether you are alive or deceased) at the completion of the study. If you still meet criteria for inclusion in the study, you will be asked to return to the hospital/research clinic for an in-person visit at 3-months after enrollment At 3 months after enrollment, you will return for an in-person study visit and will be seen by a member of the research team to evaluate your eligibility for randomization. If not eligible, you will complete your study related activities at this time and will not need to return for any in-person visits or be further contacted by the research team. The research team may, page 6 / 7

7 Powered by TCPDF ( however, obtain information from medical or public records, about your vital status (for example, whether you are alive or deceased) at the completion of the study. If eligible, you will stay on the ticagrelor for an additional 12 months but will be randomized to either to stay on the low dose aspirin, or receive a placebo (a pill that has no active ingredients) for an additional 12 months. This means that the study treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what study treatment you get. You will have an equal chance of being given each study treatment. Neither you nor the study doctor will know which study treatment you are getting. This information could be obtained in an emergency, however. For randomized subjects only: At 4 months after enrollment, you will be contacted (by phone or mail) by a member of the research team to see how you are doing At 9 months after enrollment, you will return for an in-person visit and must bring all distributed drug bottles with you (including empty, opened or unopened) so that the number of pills you have taken can be counted before new pills are given to you. Unless otherwise not indicated, study drug (ticagrelor plus aspirin or placebo) will be given to you during this visit and information about how you have been doing will be collected. At 15 months after enrollment, you will return for an additional in-person visit. You must bring the empty or unused bottles with you so that the number of pills you have taken can be counted. Information about how you have been doing will also be collected. You will no longer be taking study drug after this visit. At 18 months after enrollment, you will be contacted (by phone or mail) by a member of the research team to see how you are doing. page 7 / 7