Patients with multivessel coronary artery disease requiring staged, ischemia-guided PCI MedDRA version: 20.0 Level: LLT Classification code 10074572 Term: Multiple vessel coronary artery disease System Organ Class: 100000004849
Conditions
Interventions
Trade Name: BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 60 COMPRESSE
Product Name: BRILIQUE
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TICAGRE
Sponsors
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated Informed Consent obtained prior to the inclusion in the trial 2. Age > 18 and 60 Kg (inclusive) 4. Patients must have a clinical indication to undergo scheduled FFR-guided PCI. We will include two types of stable patients: 1) purely stable patients undergoing scheduled FFR-guided PCI of any vessel 2) patients presenting initially with acute coronary syndrome, with an intermediate coronary lesion (40%-80% in severity, where functional evaluation with FFR must be used on clinical grounds) in a non-culprit artery, and needing staged FFR-guided PCI (at least one month after the ACS) 5. Patients may be already on treatment with either Ticagrelor (mainly previous ACS patients) or Clopidogrel (purely stable patients) Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to aspirin, clopidogrel, ticagrelor or any excipients 2. Concomitant oral anticoagulant therapy, or likely need for it (e.g. atrial fibrillation) 3. Need for concomitant cardiac procedure, such as valve repair or replacement 4. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm) 5. Any active pathological bleeding or history of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months, other bleeding diathesis, or considered by investigator to be at high risk for bleeding 6. Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers. Any of such concomitant treatment will be mapped and evaluated by the Investigator in order to comply with the exclusion criteria 7. Increased risk of bradycardia events 8. Known pregnancy and/or breast-feeding 9. Severe uncontrolled chronic obstructive pulmonary disease 10. Concomitant theophylline/aminophylline use 11. Baseline ECG with serious conduction abnormalities (i.e. LVH with repolarization abnormality, left bundle branch block, ST-segment 12. Evidence of prior myocardial infarction by cardiac imaging in the territory of the index vessel 13. Depressed left ventricular systolic function at randomization (ejection fraction < 40% within 48 hours before index PCI) 14. Clinical congestive heart failure 15. Presence of coronary collaterals on diagnostic coronary angiography 16. Diffuse obstructive disease (= 70% stenosis) in the distal segment of the target vessel 17. Left main and/or three-vessel coronary artery disease 18. End-stage renal disease 19. Known severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ticagrelor may trigger ischemic preconditioning as compared to clopidogrel in patients with stable coronary disease, showing multivessel coronary artery disease and undergoing staged PCI;Secondary Objective: Ticagrelor may improve microvascular perfusion in the myocardium of patients with multivessel coronary artery disease undergoing staged PCI;Primary end point(s): Delta (difference) ST-segment elevation by intracoronary ECG during two-step sequential coronary balloon inflation in the culprit vessel;Timepoint(s) of evaluation of this end point: 20 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Angina score during coronary balloon inflation;Timepoint(s) of evaluation of this end point: 20 months | — |
Countries
Italy
Contacts
Public ContactCRO ACCADEMICA
CLINICAL TRIAL CENTER
Outcome results
None listed