TICAGRELOR for Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"-\tInformed Consent signed and dated.\n-\tPatients deemed at HBR according to standard definitions (i.e. PRECISE-DAPT ≥25 or HBR-ARC with at least 1 major or 2 minor criteria)\n-\tTreated with PCI due to a recent ACS (i.e. unstable angina, non-ST segment elevated myocardial infarction or ST segment elevated myocardial infarction) 30 ±7 days earlier.\n-\tTreated with DAPT with full-dose potent P2Y12 inhibitors (e.g. prasugrel 10mg or ticagrelor 90mg bid) according to international guidelines recommendations"}

Exclusion criteria

• {"criterion_text":"Age < 18 years\n•\tInability to follow the procedures of the study (language problems, mental disorders, dementia) or comorbidities associated with less than 12 months-life expectation (active malignancies drug or alcohol abuse, etc.) or other conditions that might result in protocol non­compliance.\nKnown intolerance, hypersensitivity or contraindication (including active bleeding) to aspirin, clopidogrel, prasugrel, ticagrelor or to any of the excipients\nIndication to oral anticoagulation\nIndication to prolonged treatment with full-dose potent P2Y12 inhibitors (e.g. previous stent thrombosis, stenting of last remaining vessel, stent with indication for longer-term DAPT, perceived very high coronary ischemic risk etc.)\nAny planned major surgery or interventional procedure requiring treatment modification\nPrior transient ischemic attack, ischemic or haemorrhagic stroke\nSevere hepatic insufficiency (Child-Pugh class C)\nOngoing therapy with strong CYP3A inducers or strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir etc.)\n•\tWomen who are pregnant, breast feeding or of childbearing potential (i.e. fertile, following menarche and who are not surgically sterile, including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or post-menopausal defined as no menses for 12 months without an alternative medical cause); Participation in another study with investigational drug within the 30 days, or 5 half-lives of the study drug whichever is longer, preceding and during the present study"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study is the incidence of optimal platelet reactivity (OPR) measured by means of the VerifyNow system (Accumetrics, San Diego, CA, USA), 2 hours after drug MD at 14±2 days from study inclusion. OPR will be defined as a PRU between 85 and 208 reactivity units according to international expert consensus","definition_or_measurement_approach":"Measured by the VerifyNow system 2 hours after drug maintenance dose at 14±2 days from inclusion. OPR defined as PRU between 85 and 208 reactivity units according to international expert consensus."}

Secondary endpoints

• {"endpoint_text":"- Key secondary endpoint of the study is the incidence of nuisance, minor or major bleeding according to the BARC definition (BARC 1-5).","definition_or_measurement_approach":"Bleeding classified according to the BARC 1-5 definition assessed at 5 months after randomization."}
• {"endpoint_text":"- Platelet reactive units (PRU) at VerifyNow system before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration and before MD at 14±2 days from study inclusion.","definition_or_measurement_approach":"PRU measured using the VerifyNow system at baseline, 2 hours after first randomized dose, and before maintenance dose at 14±2 days."}
• {"endpoint_text":"- The proportion of high platelet reactivity (HPR) defined as PRU > 208, and the proportion of low platelet reactivity (LPR), defined as PRU < 85, measured through the VerifyNow system before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration, before MD at 14±2 days from study inclusion and at 2 hours after drug MD administration at 14±2 days from study inclusion. PRU at 1 and 2 weeks after P2Y12 inhibitor discontinuation study in pa","definition_or_measurement_approach":"HPR = PRU > 208; LPR = PRU < 85 measured by VerifyNow at specified timepoints (baseline, 2h post-dose, before MD at 14±2 days, 2h after MD at 14±2 days)."}
• {"endpoint_text":"- Platelet-derived thrombogenicity at Total Thrombus Formation (T-TAS) before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration, before and after MD at 14±2 days from study inclusion","definition_or_measurement_approach":"T-TAS assessment of platelet-derived thrombogenicity at baseline, 2h after first dose, before and after maintenance dose at 14±2 days."}
• {"endpoint_text":"- Adverse clinical events, assessed at each visit and up to 5 months after randomization. They include: death, cardiac death, non-fatal myocardial infarction, non-fatal stroke, urgent target vessel revascularization, definite/probable stent thrombosis and net adverse clinical events.","definition_or_measurement_approach":"Clinical events collected at visits and up to 5 months post-randomization; specific event definitions not detailed here beyond listed event types."}
• {"endpoint_text":"- Cost-effectives analysis will be also carried out by inputting direct and indirect costs in relation to outcomes assessed.","definition_or_measurement_approach":"Economic analysis using direct and indirect costs related to assessed outcomes (methodology not detailed here)."}
• {"endpoint_text":"- Other: Health mobility and mental scales (i.e. EQ-5D-5L, SF-12); Perceived stress (i.e. PPS); Modified Borg Dyspnoea Scale, non-adherence according to the non-adherence academic research consortium (NARC) scale","definition_or_measurement_approach":"Patient-reported outcome instruments and scales (EQ-5D-5L, SF-12, PPS, Modified Borg Dyspnoea Scale, NARC) as listed; measurement approach per respective validated instruments."}

Methods

• Screening at index hospitalization for ACS or at early outpatient visit at 1 month (30 ±7 days); potential patients informed about the study and asked for participation; subjects enrolled after signing and dating informed consent form. (Country: Italy)

Italy

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

14-05-2024

Processing Time Days

82

Number Of Sites

7

Number Of Participants

200

Primary sponsor

Full Name

Azienda Ospedaliera Universitaria Gaetano Martino Messina

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Mediolanum Cardio Research S.r.l.","duties_or_roles":"codes: 12,6,7,8","organisation_type":"Pharmaceutical company"}