The IDEAL-PCI Extended Registry (IDEAL-PCI ext)

Kaiser Franz Josef Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Coronary Arterioscleroses; Platelet Dysfunction Due to Drugs

Treatments: Drug: DAPT intensification; Drug: DAPT on-target; Drug: DAPT reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT02974777

IDEAL-PCI v.2

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).

IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all consecutive PCI patients

Exclusion criteria

• pregnancy

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Bleeding prevention group

Active Comparator group

Description:

Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor

Treatment:

Drug: DAPT reduction

Drug: DAPT on-target

Ischemia prevention group

Active Comparator group

Description:

Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor

Treatment:

Drug: DAPT intensification

Drug: DAPT on-target