NCT02032303

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 Prasugrel and Ticagrelor .

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions. Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System. Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.

Conditions

• Acute Coronary Syndrome
• Non ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction
• Unstable Angina

Interventions

Type	Name	Description
PROCEDURE	Assessment of coronary flow reserve
PROCEDURE	Percutaneous Coronary Intervention
DRUG	Ticagrelor loading
DRUG	Prasugrel loading

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• First posted: 2014-01-10
• Last updated: 2014-01-10

Locations

1 site across 1 country: Italy