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Year : 2016  |  Volume : 1  |  Issue : 4  |  Page : 154-159

Assessment of coronary flow reserve by Doppler flow wIre in patients with acute coronary syndrome undergoing percutaneous coronary intervention: differences between the LoAding dose of Ticagrelor versus prasugrEl (DILATE): study protocol for a randomized controlled trial

1 Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, "Sapienza" University of Rome, Rome, Italy
2 Cardiology Unit, Ospedali Riuniti Anzio-Nettuno, Rome, Italy

Correspondence Address:
Massimo Mancone
Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, "Sapienza" University of Rome, Rome
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2468-5658.196982

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Background: Percutaneous coronary intervention (PCI) is the main treatment in patients with acute coronary syndromes (ACS). Current guidelines recommend the administration of a loading dose of clopidogrel, ticagrelor or prasugrel during the procedure. Ticagrelor and prasugrel have proven to overcome some limitation related to clopidrogrel administration as of pharmacological resistance. P2Y12 antagonists increase adenosine concentration by inhibiting red blood cells reuptake and induces adenosine triphosphate release from human red blood cells, which is further degraded to adenosine. Ticagrelor has been demonstrated to increase the coronary blood flow velocity more than prasugrel, as assessed by transthoracic Doppler echocardiography after incremental doses of adenosine administration. Currently, no data are available on comparison between prasugrel and clopidrogrel in term of vasodilation effect evaluated invasively. Methods/Design: This prospective, single-center, investigator-initiated, randomized controlled trial will compare the adenosine induced coronary dilatation after the treatment with ticagrelor (180 mg) versus prasugrel (60 mg) in patients with ACS undergoing PCI. A total of 90 patients, aged ≥ 18 and ≤ 75 years, admitted with ACS, treated by PCI with stent implantation and with a second intermediate non-culprit lesion will be included and randomized 1:1 to prasugrel (60 mg) or ticagrelor (180 mg). Coronary flow reserve (CFR), the study endpoint, will be recorded before the stent implantation on the intermediate lesion, then immediately after the stent implantation and during the adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 μg/kg/min with 2-minute interval between infusions. Discussion: Our clinical trial, for the first time, will evaluate the supposed adenosine induced effect of the ticagrelor in terms of coronary vasodilatation calculated by CFR. Currently, CFR represents the gold standard to assess the ability of the myocardium to increase blood flow in response to maximal exercise. Furthermore, this trial will be the first to compare the effects of ticagrelor versus prasugrel on patients ACS. This trial will allow to better understand the physiological pathway of coronary vasodilatiation induced by ticagrelor versus prasugrel using invasive methods. Trial registration: ClinicalTrials.gov identifier: NCT02032303; registered on December 18, 2013. Ethics: The study was approved by the Ethics Committee of Policlinico Umberto I Rome Hospital (approval No. 2322/15) and will be performed in accordance with the ethical standards of the responsible committee on human experimentation and the Declaration of Helsinki. Informed consent: A signed informed consent will be given by each patient with ACS before undergoing angiography.

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