Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study investigates whether a platelet function testing guided approach with a short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).
Patients suffering of heart attack have highly activated blood platelets. During and after invasive treatment of blocked coronary vessels (percutaneous coronary intervention = PCI) a potent platelet inhibition is needed to reduce the risk of thrombotic complications which is particularly high within the first week after PCI. On the other hand, the use of potent platelet inhibitors such as prasugrel is associated with higher bleeding risk particularly when used at long-term. A combination of a potent antiplatelet drug (prasugrel) within the first week with a less potent antiplatelet drug (clopidogrel) thereafter might lead to a higher net clinical benefit - means less bleeding and thrombotic complications. This hypothesis is being investigated in the current trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Active Comparator | Prasugrel 5 mg or 10mg daily for 12 months. |
|
| Prasugrel/Clopidogrel | Experimental | Day 0 - 7 Prasugrel 5 or 10mg Day 8 - 14 Clopidogrel 75mg q/d. On Day 14 platelet function testing Patients with HPR will be switched to Prasugrel the others will remain on Clopidogrel for 11 1/2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | see Arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding events BARC class ≥2 | 12 months | |
| stent thrombosis | 12 months | |
| all-cause death |
| Measure | Description | Time Frame |
|---|---|---|
| economic impact of a platelet function testing guided tailored treatment for ACS patients | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dirk Sibbing, MD | Munich University Hospital | Principal Investigator |
| Julinda Mehilli, MD | Munich University Hospital | Principal Investigator |
| Steffen Massberg, MD | Munich University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizin-Universität Graz, Univ. Klinik für Innere Medizin | Graz | 8036 | Austria | |||
| Wilhelminenspital Wien, 3. Medizinische Abteilung |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28855078 | Derived | Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28. | |
| 27652610 |
| Label | URL |
|---|---|
| Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clopidogrel | Drug | see arm description |
|
|
| 12 months |
| Vienna |
| 1160 |
| Austria |
| Klinikum Augsburg, Department of Cardiology | Augsburg | 86156 | Germany |
| Heart Center Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Asklepios Stadtklinik Bad Tölz, Internal Medicine | Bad Tölz | 83646 | Germany |
| St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology | Bochum | 44791 | Germany |
| Herzzentrum der Universität zu Köln | Cologne | 50937 | Germany |
| Universitätsklinikum Frankfurt, Department of Cardiology | Frankfurt | 60590 | Germany |
| Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen | Füssen | 87629 | Germany |
| Heart Center at the University Medical Center Goettingen | Göttingen | 37075 | Germany |
| Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B | Greifswald | 17475 | Germany |
| Universitäres Herzzentrum Hamburg, UKE | Hamburg | 20246 | Germany |
| University Hospital Mainz, Department of Cardiology | Mainz | 55131 | Germany |
| Klinikum Memmingen, Innere Medizin I | Memmingen | 87700 | Germany |
| Munich University Hospital | Munich | 81377 | Germany |
| Klinikum Neuperlach, Department of Cardiology | Munich | 81737 | Germany |
| Klinikum Bogenhausen, Department of Cardiology | Munich | 81925 | Germany |
| Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie | Oldenburg | 26133 | Germany |
| Universitätsmedizin Rostock, Zentrum für Innere Medizin | Rostock | 18057 | Germany |
| Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie | Siegburg | 53721 | Germany |
| University Hospital of Tuebingen, Department of Cardiology | Tübingen | 72076 | Germany |
| Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II | Weiden | 92637 | Germany |
| Semmelweis Egyetem Kardiovaszkuláris Centrum | Budapest | 1122 | Hungary |
| Budapest Military Hospital | Budapest | 1134 | Hungary |
| Heart Center Balatonfüred | Budapest | 8230 | Hungary |
| Department of Cardiology Petz Aladár Megyei Oktató Kórház | Győr | 9023 | Hungary |
| Heart Center Kecskemet | Kecskemét | 6000 | Hungary |
| PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg | Pécs | 7624 | Hungary |
| Heart Center Szeged | Szeged | 6720 | Hungary |
| 3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice | Katowice | 40635 | Poland |
| 1st Department of Cardiology, Poznan University of Medical Science | Poznan | 61848 | Poland |
| 1st Department of Cardiology, Medical University of Warsaw | Warsaw | 2097 | Poland |
| Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw | Warsaw | 2795 | Poland |
| Derived |
| Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Gori T, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Thalmeier A, Low A, Holdt L, Teupser D, Ince H, Felix SB, Parma R, Malek L, Horstkotte J, Baylacher M, Schwinger R, Rieber J, Mudra H, Hausleiter J, Huber K, Neumann FJ, Koltowski L, Huczek Z, Mehilli J, Massberg S; TROPICAL-ACS Investigators. A randomised trial on platelet function-guided de-escalation of antiplatelet treatment in ACS patients undergoing PCI. Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial. Thromb Haemost. 2017 Jan 5;117(1):188-195. doi: 10.1160/TH16-07-0557. Epub 2016 Sep 22. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided