TAILOR

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Trade Name: Plavix Product Name: Plavix Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL CAS Number: 113665‐84‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Trade Name: Efient Product Name: Efient Pharmaceutical Form: Tablet INN or Proposed INN: Prasugrel Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5‐10 CONDITION: Patientens undergoing elective, subacute or acute percutaneous coronary intervention (PI) ; MedDRA version: 12.1 Level: LLT Classification code 10028601 Term: Myocardial ischemia PRIMARY OUTCOME: Main Objective: To implement platelet function screening by MULTIPLATE analysis as a routine evaluation in all patients undergoing PCI.; Primary end point(s): Trombocyte inhibition by Multiplate analysis at 30 days Secondary Objective: To evaluate whether a strategy of switching to a different drug Efient is superior to increasing maintenance dose of Plavix with regards to improving platelet inhibition. The primary endpoint would be platelet inhibition at 30 days after inclusion in the trial. Secondary endpoints would be the combination of death, non‐fatal myocardial infarction or stroke at 90 days and 12 months and bleeding episodes at 90 days and 12 months.; ; INCLUSION CRITERIA: All patients scheduled for coronary angiography and percutaneous coronary intervention at Rigshospitalet are subjects to screening. Response to already initiated antithrombotic treatment therapy is evaluated by MULTIPLATE analysis. Only “low‐responders” by local laboratory cut off definition– an estimated 20% of the screened patients‐ are subject to randomization. The patients have to be 18 years or older 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 62c97b014e4b7e615b5eb437b7fbaf81270c15cf
First added on: Aug 22, 2024