The IDEAL-PCI Extended Registry

NCT ID: NCT02974777

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Arterioscleroses Platelet Dysfunction Due to Drugs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bleeding prevention group

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

Group Type ACTIVE_COMPARATOR

DAPT reduction

Intervention Type DRUG

Reduction of standard dose DAPT due to low platelet reactivity

DAPT on-target

Intervention Type DRUG

Standard DAPT within the therapeutic window of platelet reactivity

Ischemia prevention group

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

Group Type ACTIVE_COMPARATOR

DAPT on-target

Intervention Type DRUG

Standard DAPT within the therapeutic window of platelet reactivity

DAPT intensification

Intervention Type DRUG

Intensification of standard dose DAPT due to high platelet reactivity

Interventions

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DAPT reduction

Reduction of standard dose DAPT due to low platelet reactivity

Intervention Type DRUG

DAPT on-target

Standard DAPT within the therapeutic window of platelet reactivity

Intervention Type DRUG

DAPT intensification

Intensification of standard dose DAPT due to high platelet reactivity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all consecutive PCI patients

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Franz Josef Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Guenter Christ

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guenter Christ, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Franz Josef Hospital

Locations

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Kaiser Franz Josef Hospital

Vienna, , Austria

Site Status

Countries

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Austria

Related Links

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Other Identifiers

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IDEAL-PCI v.2

Identifier Type: -

Identifier Source: org_study_id

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