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Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers.
Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.
The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.
Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers.
These drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted.
Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.
The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily drug administration | Experimental | Patients will be given cardiovascular drugs once daily |
|
| Twice daily drug administration | Experimental | Patients will be given cardiovascular drugs twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin, Atorvastatin, Perindopril | Drug | Cardiovascular drugs will be administered all together every day at the same time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Outcome Event (MACE) | The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization | Up to 1 year |
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Inclusion Criteria:
Ischemic heart disease, willing to participate, compliance to medical therapy
Exclusion Criteria:
Patients with acute coronary syndrome; pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pelliccia | Contact | +390633062615 | f.pelliccia@mclink.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Marazzi | San Raffaele Pisana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Pisana | Rome | 00100 | Italy | |||
| Sapienza University |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000069059 | Atorvastatin |
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Patients will be randomized into two parallel groups
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| Rome |
| 00161 |
| Italy |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |