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Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Active Comparator | A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily |
|
| Prasugrel | Active Comparator | A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel | Day 2 post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of low responders in ticagrelor or prasugrel group | Low platelet response is defined as platelet aggregation values >=468 AU*min | Day 2 post randomization |
| Proportion of enhanced responders in ticagrelor or prasugrel group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharina Mayer, MD | Contact | +49-89-1218-2020 | mayer.katharina@dhm.mhn.de | |
| Isabell Bernlochner, MD | Contact | +49-89-1218-0 | isabell.bernlochner@gmx.de |
| Name | Affiliation | Role |
|---|---|---|
| Katharina Mayer, MD | Deutsches Herzzentrum München | Principal Investigator |
| Martin Orban, MD | Klinikum der Ludwig-Maximilian-Universität München, Campus Großhadern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum | Recruiting | München | Bavaria | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19264241 | Background | Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030. | |
| 17982182 | Background |
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| Prasugrel | Drug | A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years |
|
Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min
| Day 2 post randomization |
| Daniel Aradi, MD |
| Heart Center Balatonfüred, Dept. of Cardiology |
| Principal Investigator |
| Klinikum der Ludwig-Maximilians-Universität München | Recruiting | München | Bavaria | 81377 | Germany |
|
| Heart Center Balatonfüred, Dept. of Cardiology | Not yet recruiting | Balatonfüred | 8230 | Hungary |
|
| Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4. |
| 19717846 | Background | Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 |
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