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Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Experimental | single-dose loading with 60 mg of prasugrel pre PCI |
|
| Clopidogrel | Active Comparator | loading with 600 mg of clopidogrel pre PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | see arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined ischemic events | Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Academic Research Consortium ≥2 bleeding and TIMI classification | 30 days |
| Peri-PCI MI Type 4a | according to Third Universal Definition of MI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julinda Mehilli, MD | University Hospital Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Freiburg, Bad Krozingen | Freiburg im Breisgau | Bad Krozingen | 79189 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32527192 | Derived | Mehilli J, Baquet M, Hochholzer W, Mayer K, Tesche C, Aradi D, Xu Y, Thienel M, Gschwendtner S, Zadrozny M, Jochheim D, Sibbing D, Schupke S, Mansmann U, Hoffmann E, Kastrati A, Neumann FJ, Massberg S. Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008649. doi: 10.1161/CIRCINTERVENTIONS.119.008649. Epub 2020 Jun 12. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Clopidogrel | Drug | see arm description |
|
|
| 30 days |
| All-cause death | mortality | 30 days |
| Any myocardial infarction | according to SASSICAIA protocol definition | 30 days |
| Stent thrombosis | according to Academic Research Consortium criteria | 30 days |
| Urgent vessel revascularization | revascularization related to symptoms | 30 days |
| cerebro-vascular events | stroke and TIA | 30 days |
| Munich University Hospital |
| Munich |
| Bavaria |
| 81377 |
| Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Klinikum Bogenhausen | Munich | Germany |
| Heart Center Balatonfüred and Heart and Vascular Center | Balatonfüred | Hungary |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |