Assessment of improvement of the coronary flow after the administration of two different antiplatelet drugs (Ticagrelor or Prasugrel)

Phase 1

• Conditions: Patients with acute coronary syndrome; MedDRA version: 20.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10002388Term: Angina unstableSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000197-19-IT
• Lead Sponsor: MBERTO I - POLICLINICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with ACS (acute coronary syndromes) undergoing PCI with
stent implantation;
• Patients = 18 and = 75 years old;
• Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• Patients with stable angina;
• prior myocardial infarction;
• prior revascularization (PCI or CABG-coronary artery bypass
grafting);
• Prasugrel and/or Ticagrelor contraindications (history of intracranial
hemorrhage, active pathological bleeding, severe hepatic impairment);
• major periprocedural complications;
• GFR ( glomerular filtration rate) < 30 ml/min or requiring
haemodialysis;
• Non-sinus rhythm;
• severe COPD (chronic obstructive pulmonary disease);
• requirement for oral anticoagulant;
• risk of bleeding or bradycardic events;
• EF (ejection fraction) < 45%;
• Cardiogenic shock;
• Severe left ventricular hypertrophy;
• severe valvular disease;
• indication to CABG;
• diffuse coronary atherosclerosis;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In the present study we aim to compare the adenosine induced coronary dilatation after the loading dose of Ticagrelor (180 mg) versus Prasugrel (60 mg) in patients with ACS (acute coronary syndromes) undergoing PCI (percutaneous coronary intervention).;Secondary Objective: Not applicable;Primary end point(s): To investigate the enhancement of Adenosine-induced coronary vasodilatation in terms of max-CFR after the loading dose of Ticagrelor (180 mg) either Prasugrel (60 mg) in patients with ACS undergoing PCI, at gradually increasing doses of adenosine.;Timepoint(s) of evaluation of this end point: About 3 hours after the loading dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess if higher plasmatic concentrations of Ticagrelor are related to higher CFR at gradually increasing doses of Adenosine;;Timepoint(s) of evaluation of this end point: About 2-4 hours after PCI