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The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel low dose | Experimental | Patient will be randomized to this intervention will receive prasugrel 5 mg and after 15 days and 30 days we will control the responsivness of the study drug. |
|
| Clopidogrel standard dose | Experimental | Patient will be randomized to this intervention will receive clopidogrel 75 mg and after 15 days and 30 days we will control the responsivness of the study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Patient will be randomized to this intervention will receive the standard dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| superiority of prasugrel low dose | The primary aim will be to investigate the antiplatelet effect of half dose of prasugrel (5 mg) versus standard dose of clopidogrel in patients with acute coronary syndrome and coronary diseases, treated with percutaneous coronary intervention and stent implantation. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Bleeding (major, minor, or minimal according to the TIMI study criteria) | 12 months |
| major adverse cardiac events | major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gennaro Sardella, MD | Contact | +390649979035 | rino.sardella@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept.of Cardiovascular Sciences,Policlinico Umberto I | Rome | Rome | 000161 | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Prasugrel | Drug | Patient will be randomized to this intervention will receive the low dose of prasugrel and after 15 days and 30 days we will control the responsivness of the study drug. |
|
| 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |