Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
Coronary Stent Implantation
Drug: prasugrel or ticagrelor
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry|
- Definite Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
- Any Bleeding Event [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
Bleeding classified by the TIMI hemorrhage classification scheme:
Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin of 3 to < 5 g/dL
Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL
- Probable Stent Thrombosis [ Time Frame: 30days ] [ Designated as safety issue: No ]
Probable stent thrombosis is considered to have occurred in case of
- any unexplained death within the first 30 days.
- any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure
|Study Start Date:||July 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: standard therapy
standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
clopidogrel 75mg od for 12 month
Other Name: Plavix
Experimental: individualized therapy
dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Drug: prasugrel or ticagrelor
prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.