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The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).
Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT | Experimental | "Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die |
|
| SAPT | Active Comparator | "Single antiplatelet therapy": acetylsalicylic acid 100 mg/die |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 90 mg bis in die |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac-related mortality | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Overall mortality and non-cardiac-related mortality | 5 years |
| Major adverse cardiac and cerebrovascular events (MACCEs) | cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke |
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Inclusion Criteria:
Exclusion Criteria:
Exit Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Nenna, MD | Contact | +393337014743 | a.nenna@unicampus.it | |
| Massimo Chello, MD | Contact | m.chello@unicampus.it |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Chello, MD | Università Campus Bio-Medico di Roma, Rome, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Bio-Medico di Roma | Recruiting | Rome | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27665400 | Result | Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| acetylsalicylic acid |
| Drug |
100 mg die |
|
| 5 years |
| Major adverse hemorrhagic events (MAHEs) | stroke, gastrointestinal bleeding, life-threatening bleeding | 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |