Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kaiser Franz Josef Hospital
- Enrollment
- 1,008
- Locations
- 1
- Primary Endpoint
- Definite Stent Thrombosis
Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all consecutive PCI patients with stent implantation of our institution
Exclusion Criteria
- •pregnancy
Arms & Interventions
standard therapy
standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
Intervention: Clopidogrel (Drug)
individualized therapy
dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Intervention: prasugrel or ticagrelor (Drug)
Outcomes
Primary Outcomes
Definite Stent Thrombosis
Time Frame: 30 days
The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
Any Bleeding Event
Time Frame: 30days
Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop 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
Secondary Outcomes
- Probable Stent Thrombosis(30days)
Investigators
Prof. Dr. Guenter Christ
Univ. Prof. Dr.
Kaiser Franz Josef Hospital