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| Name | Class |
|---|---|
| ANMCO Italian Association of Hospital Cardiologist | UNKNOWN |
| Italian Society of Invasive Cardiology | OTHER |
| A. Manzoni Hospital | OTHER |
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The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prasugrel | Experimental | prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up |
|
| clopidogrel | Active Comparator | Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prasugrel | Drug | prasugrel 5 mg o.d. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The composite of burden of recurrent cardiovascular (CV) events, CV mortality, all-cause mortality and MI, major bleeding, any stroke, total number of days spent in hospital. | definition of major bleeding: - Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 1 year (for bleedings occurring during index or subsequent hospitalizations) · BARC type IV bleeding within 1 year | 1 year |
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Inclusion Criteria:
- Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.
STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcispedale Santa Maria Nuova- IRCCS | Reggio Emilia | Italy | 42123 | Italy | ||
| Azienda Ospedaliera "Ospedale Civile di Legnano" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30636561 | Derived | Crimi G, Morici N, Ferrario M, Ferri LA, Piatti L, Grosseto D, Cacucci M, Mandurino Mirizzi A, Toso A, Piscione F, De Carlo M, Elia LR, Trimarco B, Bolognese L, Bovenzi FM, De Luca G, Savonitto S, De Servi S. Time Course of Ischemic and Bleeding Burden in Elderly Patients With Acute Coronary Syndromes Randomized to Low-Dose Prasugrel or Clopidogrel. J Am Heart Assoc. 2019 Jan 22;8(2):e010956. doi: 10.1161/JAHA.118.010956. | |
| 29459361 |
| Label | URL |
|---|---|
| Design and rationale of the randomized Elderly-ACS 2 study | View source |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
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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 | 75 mg o.d. |
|
|
| Legnano |
| MI |
| 20025 |
| Italy |
| Derived |
| Savonitto S, Ferri LA, Piatti L, Grosseto D, Piovaccari G, Morici N, Bossi I, Sganzerla P, Tortorella G, Cacucci M, Ferrario M, Murena E, Sibilio G, Tondi S, Toso A, Bongioanni S, Ravera A, Corrada E, Mariani M, Di Ascenzo L, Petronio AS, Cavallini C, Vitrella G, Rogacka R, Antonicelli R, Cesana BM, De Luca L, Ottani F, De Luca G, Piscione F, Moffa N, De Servi S; Elderly ACS 2 Investigators. Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization. Circulation. 2018 Jun 5;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180. Epub 2018 Feb 19. |
| 27823681 | Derived | Ferri LA, Morici N, Grosseto D, Tortorella G, Bossi I, Sganzerla P, Cacucci M, Sibilio G, Tondi S, Toso A, Ferrario M, Gandolfo N, Ravera A, Mariani M, Corrada E, Di Ascenzo L, Petronio AS, Cavallini C, Moffa N, De Servi S, Savonitto S. A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study. Am Heart J. 2016 Nov;181:101-106. doi: 10.1016/j.ahj.2016.08.010. Epub 2016 Aug 26. |
| D001157 |
| Arterial Occlusive Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |