Ticagrelor for ST-elevation myocardial infarction (STEMI)

Inclusion criteria

• {"criterion_text":"- Diagnosis of ST-elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (pPCI)\n- age 18 years or older\n- informed consent provided\n- Clinical indication to administer cangrelor and ticagrelor."}

Exclusion criteria

• {"criterion_text":"- Any conditions that, in the opinion of the investigator, contraindicates antiplatelet therapy or would have an unacceptable risk of bleeding.\n- Clinically significant ongoing bleeding.\n- Injuries or conditions that significantly increase the risk of major bleeding (these may include recent or ongoing gastric ulceration, presence of cancer with high risk of bleeding, recent brain or spinal trauma, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular dysfunctions).\n- Hypersensitivity to the active substance or to any of the excipients.\n- Known end stage renal disease on hemodialysis.\n- Known severe hepatic dysfunction.\n- Acute or severe bronchial asthma or upper airway obstruction.\n- Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.\n- Treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) within 7 days.\n- Treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban) within 7 days.\n- Known platelet count <100x106/mL.\n- Known hemoglobin <10 g/dL.\n- Known hematocrit < 28% \n- Pregnancy (to be ascertained with pregnancy tests in women of childbearing potential) and breastfeeding.\n- Inability to provide informed consent."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the incidence of high platelet reactivity (HPR), defined as a measured closure time (CT) ≤ 106 seconds, at predefined time points after cangrelor interruption, assessed by platelet function analyzer (PFA)-200 P2Y test, in Early Group compared to Delayed Group.","definition_or_measurement_approach":"Incidence of high platelet reactivity (HPR) defined as measured closure time (CT) ≤ 106 seconds measured at predefined time points after cangrelor interruption using the platelet function analyzer (PFA)-200 P2Y test."}

Secondary endpoints

• {"endpoint_text":"- Difference in mean measured CT.","definition_or_measurement_approach":"Mean measured closure time (CT) as assessed by platelet function analyzer (PFA)-200 P2Y test."}
• {"endpoint_text":"- Incidence of major adverse cardiovascular events (MACE) within 30 days.","definition_or_measurement_approach":"Occurrence of MACE within 30 days (no further definition provided in source)."}
• {"endpoint_text":"- Mortality within 30 days.","definition_or_measurement_approach":"All-cause mortality within 30 days (no further definition provided)."}
• {"endpoint_text":"- Incidence of stent thrombosis within 30 days.","definition_or_measurement_approach":"Occurrence of stent thrombosis within 30 days (no further definition provided)."}
• {"endpoint_text":"- Incidence of unplanned revascularization within 30 days.","definition_or_measurement_approach":"Occurrence of any unplanned revascularization within 30 days (no further definition provided)."}
• {"endpoint_text":"- Incidence of peri-procedural infarction.","definition_or_measurement_approach":"Occurrence of peri-procedural infarction (no further definition provided)."}
• {"endpoint_text":"- Bleeding events according to the BARC criteria.","definition_or_measurement_approach":"Bleeding events classified according to the BARC (Bleeding Academic Research Consortium) criteria."}

Italy

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

13-08-2024

Processing Time Days

61

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"University of Eastern Piedmont","duties_or_roles":"Source of monetary support","organisation_type":""}