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

January 25, 2018 updated by: Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital

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

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

Study Overview

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1100
        • Kaiser Franz Josef Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all consecutive PCI patients

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bleeding prevention group
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Reduction of standard dose DAPT due to low platelet reactivity
Standard DAPT within the therapeutic window of platelet reactivity
Active Comparator: Ischemia prevention group
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Standard DAPT within the therapeutic window of platelet reactivity
Intensification of standard dose DAPT due to high platelet reactivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stent thrombosis
Time Frame: 1 year
stent thrombosis by any Academic Research Consortium (ARC) definition
1 year
bleeding
Time Frame: 1 year
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular Events (MACCE)
Time Frame: 1 year
death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guenter Christ, MD, Kaiser Franz Josef Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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