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

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 and PrasugrEl. - DELATE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000197-19-IT

Enrollment

Registered

2021-10-01

Start date

2015-07-23

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute coronary syndrome MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10002388 Term: Angina unstable System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 56 COMPRESSE (CONF. CALENDARIZZATA) Product Name: Ticagrelor Pharmaceutical Form: Film-coated tablet Tr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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;

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactEmodinamica A

Umberto I - Policlinico di Roma

massimomancone@gmail.com+390649979044

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026