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Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).
This is prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90mg bid for 15 days |
|
| Prasugrel | Active Comparator | Prasugrel 10mg od for 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug |
| ||
| Prasugrel |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
Acute Coronary Syndrome
Contraindication for administration of prasugrel or ticagrelor
Requirement for oral anticoagulant agents prior to the day 30 visit
History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
Increased risk for bradyarrhythmias, according to the investigator's evaluation
Severe non-controlled chronic obstructive pulmonary disease
Creatinine clearance <30ml/min/1.73mm2
HbA1c > 10mg/dl
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patras University Hospital | Pátrai | Achaia | 26500 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29292242 | Derived | Xanthopoulou I, Bei I, Bampouri T, Barampoutis N, Moulias A, Davlouros P, Alexopoulos D. Absence of differential effect of ticagrelor versus prasugrel maintenance dose on endothelial function in patients with stable coronary artery disease. Hellenic J Cardiol. 2018 Nov-Dec;59(6):338-343. doi: 10.1016/j.hjc.2017.12.008. Epub 2017 Dec 29. |
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|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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