Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Kaiser Franz Josef Hospital
- Locations
- 1
- Primary Endpoint
- 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).
IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit
Detailed Description
Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.
In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all consecutive PCI patients
Exclusion Criteria
- •pregnancy
Arms & Interventions
Bleeding prevention group
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Intervention: DAPT reduction (Drug)
Bleeding prevention group
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Intervention: DAPT on-target (Drug)
Ischemia prevention group
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Intervention: DAPT on-target (Drug)
Ischemia prevention group
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Intervention: DAPT intensification (Drug)
Outcomes
Primary Outcomes
stent thrombosis
Time Frame: 1 year
stent thrombosis by any Academic Research Consortium (ARC) definition
bleeding
Time Frame: 1 year
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
Secondary Outcomes
- Major adverse cardiac and cerebrovascular Events (MACCE)(1 year)
Investigators
Prof. Dr. Guenter Christ
Prof
Kaiser Franz Josef Hospital