Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Kaiser Franz Josef Hospital

Status and phase: Completed; Phase 3

Conditions: Platelet Inhibition; Coronary Stent Implantation

Treatments: Drug: prasugrel or ticagrelor; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01515345

IDEAL-PCI protocol 1.0

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,008 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all consecutive PCI patients with stent implantation of our institution

Exclusion criteria

• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,008 participants in 2 patient groups

standard therapy

Active Comparator group

Description:

standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)

Treatment:

Drug: Clopidogrel

individualized therapy

Experimental group

Description:

dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer

Treatment:

Drug: prasugrel or ticagrelor