A randomized, pharmacodynamic study of cangrelor administration in STEMI patients loaded with ticagrelor

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2016
INTERVENTION: Trade Name: Kengrexal Pharmaceutical Form: Powder for concentrate for solution for injection/infusion Other descriptive name: CANGRELOR TETRASODIUM Trade Name: Brilique Product Name: Ticagrelor Pharmaceutical Form: Tablet CONDITION: In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients. Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients. We hypothesize a superior antiplatelet effect of a cangrelor strategy peri‐interventionally and as early as within 15 min of cangrelor infusion. Primary end point(s): the primary end point of the study is the platelet reactivity between the two study groups in 15 minutes and will be measured in P2Y12 reaction units(PRU) Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 1 day SECONDARY OUTCOME: Secondary end point(s): Secondary end point will be the Platelet reactivity between the two groups in 1, 2, and 4 hours, and the percentange of HPR in 15 minutes, 1, 2, 4 hours Timepoint(s) of evaluation of this end point: 1 day INCLUSION CRITERIA: For patients included in the study must meet the following criteria: 1. Provide signed inform consent form for any procedure that involves the study 2. Patients with STEMI (ST segment elevation in at least two leads,> 2mm the precordial or> 1mm in inferior leads and new or suspected new‐onset LBBB) who are going to perform primary angioplasty 3. Not receiving inhibitor of P2Y12 receptor 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Epistemonikos ID: 3fa9f2cbe8679b746a364615479b802eb418991d
First added on: Aug 24, 2024