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 .

NCT ID: NCT02032303

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ticagrelor

Patient randomized to Ticagrelor

Group Type: ACTIVE_COMPARATOR

Assessment of coronary flow reserve

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Ticagrelor loading

Intervention Type: DRUG

Prasugrel

Patient randomized to Prasugrel

Group Type: ACTIVE_COMPARATOR

Assessment of coronary flow reserve

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Prasugrel loading

Intervention Type: DRUG

Interventions

Assessment of coronary flow reserve

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Ticagrelor loading

Intervention Type: DRUG

Prasugrel loading

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;

• Patients ≥ 18 and ≤ 75 years old.
• Signed informed consent;

Exclusion Criteria

• • Patients with stable angina;

• prior myocardial infarction;
• prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
• Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
• Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
• major periprocedural complications;
• suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
• glomerular filtration rate < 30 ml/min or requiring haemodialysis;
• Non-sinus rhythm;
• severe chronic obstructive pulmonary disease;
• requirement for oral anticoagulant;
• risk of bleeding or bradycardic events;
• ejection fraction < 45%;
• Cardiogenic shock;
• Severe left ventricular hypertrophy;
• severe valvular disease;
• diffuse coronary atherosclerosis;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Massimo Mancone

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massimo Mancone

Rome, Rome, Italy

Countries

Italy

Central Contacts

massimo mancone

Role: CONTACT

00390649979044

Facility Contacts

Role: primary

00390649970468

Other Identifiers

Ticagrelor - Prasugrel

Identifier Type: -

Identifier Source: org_study_id