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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002272-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental |
| |
| Prasugrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Loading dose of 180 mg, followed by maintenance dose of 180 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death, myocardial infarction or stroke | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Bleeding according to BARC | 12 months |
| Mortality | Death for any cause | 12 months |
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Major Inclusion Criteria:
Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Kastrati, MD | Deutsches Herzzentrum München | Study Chair |
| Stefanie Schuepke, MD | Deutsches Herzzentrum München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Freiburg/ Bad Krozingen | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36546322 | Derived | Bongiovanni D, Schreiner N, Gosetti R, Mayer K, Angiolillo DJ, Sibbing D, Holdenrieder S, Anetsberger A, von Scheidt M, Schunkert H, Laugwitz KL, Schupke S, Kastrati A, Fegers-Wustrow I, Bernlochner I. Immature Platelet Fraction Predicts Adverse Events in Patients With Acute Coronary Syndrome: the ISAR-REACT 5 Reticulated Platelet Substudy. Arterioscler Thromb Vasc Biol. 2023 Feb;43(2):e83-e93. doi: 10.1161/ATVBAHA.122.318614. Epub 2022 Dec 22. | |
| 36515247 |
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| Prasugrel | Drug | Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg |
|
|
| Stroke | Stroke | 12 months |
| Myocardial Infarction | 12 months |
| Stent Thrombosis | Stent thrombosis according to ARC | 12 months |
| Universitäts-Klinikum Heidelberg |
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Universitätsklinikum Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Klinikum Landkreis Erding | Erding | Bavaria | 85435 | Germany |
| Deutsches Herzzentrum Munich | München | Bavaria | 80636 | Germany |
| Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik | München | Bavaria | 81675 | Germany |
| Klinikum Neuperlach | München | Bavaria | 81737 | Germany |
| Universitätsklinikum Regensburg | Regensburg | Bavaria | 93042 | Germany |
| Klinikum Traunstein | Traunstein | Bavaria | 83278 | Germany |
| Kerckhoff-Klinik GmbH, Abteilung für Kardiologie | Bad Nauheim | Hesse | 61231 | Germany |
| Universitätsmedizin Göttingen, Herzzentrum | Göttingen | Lower Saxony | 37099 | Germany |
| Herzzentrum Wuppertal | Wuppertal | North Rhine-Westphalia | 42117 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Charité Universitätsmedizin Berlin, Campus Virchow-Klinik | Berlin | 13353 | Germany |
| Careggi University Hospital, Invasive Cardiology Division | Florence | 50141 | Italy |
| Spaziani Hospital Frosinone | Frosinone | 03100 | Italy |
| Derived |
| Lahu S, Scalamogna M, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Kastrati A, Cassese S. Prior Myocardial Infarction and Treatment Effect of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndromes - A Post-hoc Analysis of the ISAR-REACT 5 Trial. J Am Heart Assoc. 2022 Dec 20;11(24):e027257. doi: 10.1161/JAHA.122.027257. Epub 2022 Dec 14. |
| 36434779 | Derived | Aytekin A, Coughlan JJ, Ndrepepa G, Cassese S, Lahu S, Kufner S, Mayer K, Xhepa E, Gewalt S, Joner M, Hapfelmeier A, Angiolillo DJ, Menichelli M, Richardt G, Neumann FJ, Schunkert H, Kastrati A. The effect of a Prasugrel- vs. a Ticagrelor-based strategy on total ischaemic and bleeding events in patients with acute coronary syndromes. Eur Heart J Cardiovasc Pharmacother. 2023 Apr 10;9(3):231-239. doi: 10.1093/ehjcvp/pvac067. |
| 36256695 | Derived | Lahu S, Presch A, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Rifatov N, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Sibbing D, Angiolillo DJ, Kastrati A, Cassese S. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome and High Bleeding Risk. Circ Cardiovasc Interv. 2022 Oct;15(10):e012204. doi: 10.1161/CIRCINTERVENTIONS.122.012204. Epub 2022 Oct 18. |
| 35789430 | Derived | Behnes M, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Muller A, Kufner S, Hamm CW, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A, Akin I. Ticagrelor or prasugrel in patients with acute coronary syndrome with off-hour versus on-hour presentation: a subgroup analysis of the ISAR-REACT 5 trial. Clin Res Cardiol. 2023 Apr;112(4):518-528. doi: 10.1007/s00392-022-02040-z. Epub 2022 Jul 5. |
| 35045943 | Derived | Hemetsberger R, Richardt G, Lahu S, Valina C, Menichelli M, Abdelghani M, Wohrle J, Toelg R, Witzenbichler B, Mankerious N, Liebetrau C, Bernlochner I, Hamm CW, Allali A, Joner M, Fusaro M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Schupke S, Laugwitz KL, Schunkert H, Neumann FJ, Kastrati A, Cassese S. Access Route and Clinical Outcomes After Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome Undergoing Invasive Treatment Strategy. Cardiovasc Revasc Med. 2022 Aug;41:122-128. doi: 10.1016/j.carrev.2021.12.029. Epub 2022 Jan 3. |
| 34961732 | Derived | Lahu S, Behnes M, Ndrepepa G, Neumann FJ, Sibbing D, Bernlochner I, Menichelli M, Mayer K, Richardt G, Gewalt S, Angiolillo DJ, Coughlan JJ, Aytekin A, Witzenbichler B, Hochholzer W, Cassese S, Kufner S, Xhepa E, Sager HB, Joner M, Fusaro M, Laugwitz KL, Schunkert H, Schupke S, Kastrati A, Akin I. Body mass index and efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndromes. Rev Esp Cardiol (Engl Ed). 2022 Sep;75(9):747-755. doi: 10.1016/j.rec.2021.11.007. Epub 2021 Dec 24. English, Spanish. |
| 34779234 | Derived | Ndrepepa G, Neumann FJ, Menichelli M, Bernlochner I, Richardt G, Wohrle J, Witzenbichler B, Mayer K, Cassese S, Gewalt S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Laugwitz KL, Schunkert H, Schupke S, Kastrati A. Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes. J Am Heart Assoc. 2021 Nov 16;10(22):e021418. doi: 10.1161/JAHA.121.021418. Epub 2021 Nov 15. |
| 34529983 | Derived | Ndrepepa G, Holdenrieder S, Neumann FJ, Lahu S, Cassese S, Joner M, Xhepa E, Kufner S, Wiebe J, Laugwitz KL, Gewalt S, Schunkert H, Kastrati A. Prognostic value of glomerular function estimated by Cockcroft-Gault creatinine clearance, MDRD-4, CKD-EPI and European Kidney Function Consortium equations in patients with acute coronary syndromes. Clin Chim Acta. 2021 Dec;523:106-113. doi: 10.1016/j.cca.2021.09.007. Epub 2021 Sep 13. |
| 34468709 | Derived | Coughlan JJ, Aytekin A, Ndrepepa G, Schupke S, Bernlochner I, Mayer K, Neumann FJ, Menichelli M, Richardt G, Wohrle J, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Cassese S. Twelve-month clinical outcomes in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: insights from the ISAR-REACT 5 trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1117-1124. doi: 10.1093/ehjacc/zuab077. |
| 34446390 | Derived | Wohrle J, Seeger J, Lahu S, Mayer K, Bernlochner I, Gewalt S, Menichelli M, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Kufner S, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A, Ndrepepa G. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome in Relation to Estimated Glomerular Filtration Rate. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1857-1866. doi: 10.1016/j.jcin.2021.06.028. Epub 2021 Aug 23. |
| 34190967 | Derived | Coughlan JJ, Aytekin A, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Muller A, Kufner S, Liebetrau C, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schupke S, Kastrati A. Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Oct 1;6(10):1121-1129. doi: 10.1001/jamacardio.2021.2228. |
| 34130477 | Derived | Coughlan JJ, Aytekin A, Ndrepepa G, Schupke S, Bernlochner I, Mayer K, Neumann FJ, Menichelli M, Richardt G, Wohrle J, Witzenbichler B, Gewalt S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Cassese S. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome Undergoing Complex Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 Jul;14(7):e010565. doi: 10.1161/CIRCINTERVENTIONS.121.010565. Epub 2021 Jun 16. |
| 34126130 | Derived | Lahu S, Ndrepepa G, Gewalt S, Schupke S, Pellegrini C, Bernlochner I, Aytekin A, Neumann FJ, Menichelli M, Richardt G, Cassese S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Mayer K. Efficacy and safety of ticagrelor versus prasugrel in smokers and nonsmokers with acute coronary syndromes. Int J Cardiol. 2021 Sep 1;338:8-13. doi: 10.1016/j.ijcard.2021.06.011. Epub 2021 Jun 11. |
| 33213734 | Derived | Mayer K, Bongiovanni D, Karschin V, Sibbing D, Angiolillo DJ, Schunkert H, Laugwitz KL, Schupke S, Kastrati A, Bernlochner I. Ticagrelor or Prasugrel for Platelet Inhibition in Acute Coronary Syndrome Patients: The ISAR-REACT 5 Trial. J Am Coll Cardiol. 2020 Nov 24;76(21):2569-2571. doi: 10.1016/j.jacc.2020.09.586. No abstract available. |
| 33213722 | Derived | Valina C, Neumann FJ, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Aytekin A, Richardt G, Witzenbichler B, Sibbing D, Cassese S, Angiolillo DJ, Kufner S, Liebetrau C, Hamm CW, Xhepa E, Hapfelmeier A, Sager HB, Wustrow I, Joner M, Trenk D, Laugwitz KL, Schunkert H, Schupke S, Kastrati A. Ticagrelor or Prasugrel in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2020 Nov 24;76(21):2436-2446. doi: 10.1016/j.jacc.2020.09.584. |
| 33115278 | Derived | Aytekin A, Ndrepepa G, Neumann FJ, Menichelli M, Mayer K, Wohrle J, Bernlochner I, Lahu S, Richardt G, Witzenbichler B, Sibbing D, Cassese S, Angiolillo DJ, Valina C, Kufner S, Liebetrau C, Hamm CW, Xhepa E, Hapfelmeier A, Sager HB, Wustrow I, Joner M, Trenk D, Fusaro M, Laugwitz KL, Schunkert H, Schupke S, Kastrati A. Ticagrelor or Prasugrel in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Circulation. 2020 Dec 15;142(24):2329-2337. doi: 10.1161/CIRCULATIONAHA.120.050244. Epub 2020 Oct 29. |
| 33032712 | Derived | Ndrepepa G, Kastrati A, Menichelli M, Neumann FJ, Wohrle J, Bernlochner I, Richardt G, Witzenbichler B, Sibbing D, Gewalt S, Angiolillo DJ, Hamm CW, Hapfelmeier A, Trenk D, Laugwitz KL, Schunkert H, Schupke S, Mayer K. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndromes and Diabetes Mellitus. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2238-2247. doi: 10.1016/j.jcin.2020.07.032. |
| 32687741 | Derived | Menichelli M, Neumann FJ, Ndrepepa G, Mayer K, Wohrle J, Bernlochner I, Richardt G, Witzenbichler B, Sibbing D, Gewalt S, Angiolillo DJ, Lahu S, Hamm CW, Hapfelmeier A, Trenk D, Laugwitz KL, Schunkert H, Schupke S, Kastrati A. Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes : Results From a Randomized Trial. Ann Intern Med. 2020 Sep 15;173(6):436-444. doi: 10.7326/M20-1806. Epub 2020 Jul 21. |
| 31475799 | Derived | Schupke S, Neumann FJ, Menichelli M, Mayer K, Bernlochner I, Wohrle J, Richardt G, Liebetrau C, Witzenbichler B, Antoniucci D, Akin I, Bott-Flugel L, Fischer M, Landmesser U, Katus HA, Sibbing D, Seyfarth M, Janisch M, Boncompagni D, Hilz R, Rottbauer W, Okrojek R, Mollmann H, Hochholzer W, Migliorini A, Cassese S, Mollo P, Xhepa E, Kufner S, Strehle A, Leggewie S, Allali A, Ndrepepa G, Schuhlen H, Angiolillo DJ, Hamm CW, Hapfelmeier A, Tolg R, Trenk D, Schunkert H, Laugwitz KL, Kastrati A; ISAR-REACT 5 Trial Investigators. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019 Oct 17;381(16):1524-1534. doi: 10.1056/NEJMoa1908973. Epub 2019 Sep 1. |
| 24371012 | Derived | Schulz S, Angiolillo DJ, Antoniucci D, Bernlochner I, Hamm C, Jaitner J, Laugwitz KL, Mayer K, von Merzljak B, Morath T, Neumann FJ, Richardt G, Ruf J, Schomig G, Schuhlen H, Schunkert H, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 Trial Investigators. Randomized comparison of ticagrelor versus prasugrel in patients with acute coronary syndrome and planned invasive strategy--design and rationale of the iNtracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 trial. J Cardiovasc Transl Res. 2014 Feb;7(1):91-100. doi: 10.1007/s12265-013-9527-3. Epub 2013 Dec 27. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided