INTRACORONARY STENTING AND ANTITHROMBOTIC REGIMEN: ADJUSTING ANTIPLATELET TREATMENT IN PATIENTS BASED ON PLATELET FUNCTION TESTING - ISAR ADAPT-PF

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2011
INTERVENTION: Trade Name: Efient Product Name: Efient Pharmaceutical Form: Tablet INN or Proposed INN: PRASUGREL CAS Number: 150322‐43‐3 Trade Name: Brilique Product Name: Brilique Pharmaceutical Form: Tablet CAS Number: 274693‐27‐5 Other descriptive name: TICAGRELOR CONDITION: Effect of Ticagrelor and Prasugrel in patients with insufficient responding to Clopidogrel after coronary intervention (non‐inferiority of Ticagrelor vs. Prasugrel) ; MedDRA version: 17.0 Level: LLT Classification code 10003601 Term: Atherosclerosis System Organ Class: 100000004866 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Ticagrelor is not inferior to Prasugrel with regard to the inhibition of platelet aggregation in patients with insufficient response to Clopidogrel. Primary end point(s): ADP‐induced platelet aggregation on 2nd. day after randomization Secondary Objective: The objective of this clinical trial is to measure the degree of the inhibition of platelet aggregation by the two active substances Ticagrelor and Prasugrel in patients, who received a coronary stent implantation and show an insufficient responding to Clopidogrel after this intervention.; The measurement is done by means of full‐blood impedance aggregometry using Multiplate Analyzer. Timepoint(s) of evaluation of this end point: day 2 after randomization SECONDARY OUTCOME: Secondary end point(s): ‐ (1)portion of patients with insufficient inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut‐off > 468 AU*min) on the 2nd. day after randomization ; ‐ (2)portion of patients with exceeding inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut‐off < 188 AU*min) on the 2nd. day after randomization ; ‐ (3)ADP‐induced platelet aggregation, point in time: 2 weeks after randomization during Ticagrelor or Prasugrel maintenance therapy Timepoint(s) of evaluation of this end point: ‐ concerning points (1) and (2): day 2 after randomization ; ‐ concerning point (3): 2 weeks after randomization INCLUSION CRITERIA: ‐ patients after coronary intervention ‐ insufficient inhibition of platelet aggregation after Clopidogrel loading ‐ informed, written 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Epistemonikos ID: a235693cf7ec0d21f8faa30e42842ce01cda7865
First added on: Aug 22, 2024