drugset / Trial / NCT01225562
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
Timeline
- Start
- 2010-10
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- Results Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
- Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.
- Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.
- Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.
- Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.
- Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.
- Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.
- Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.
- Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.
- Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.
- Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.
- Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.
- Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.
- Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.
- Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Spinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.
- Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Theroux P, Hamm C, Spinar J, Kiss RG, Dalby AJ, Medina FA, Kontny F, Aylward PE, Jensen EC, Held P, Braunwald E, Sabatine MS. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016 Jul 1;1(4):425-32. doi: 10.1001/jamacardio.2016.1017.
- Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
- Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Dalby A, Spinar J, Aylward P, Corbalan R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.
- Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG. Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54. J Am Coll Cardiol. 2016 Jun 14;67(23):2732-2740. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.
- Bonaca MP, Bhatt DL, Steg PG, Storey RF, Cohen M, Im K, Oude Ophuis T, Budaj A, Goto S, Lopez-Sendon J, Diaz R, Dalby A, Van de Werf F, Ardissino D, Montalescot G, Aylward P, Magnani G, Jensen EC, Held P, Braunwald E, Sabatine MS. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54. Eur Heart J. 2016 Apr 7;37(14):1133-42. doi: 10.1093/eurheartj/ehv531. Epub 2015 Oct 21.
- Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ticagrelor | Small molecule | 60 mg | Oral |
| Subject | Ticagrelor | Small molecule | 90 mg | Oral |