NCT02974777

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

First QC Date

November 23, 2016

Last Update Submit

January 25, 2018

Conditions

Coronary ArteriosclerosesPlatelet Dysfunction Due to Drugs

Outcome Measures

Primary Outcomes (2)

  • stent thrombosis

    stent thrombosis by any Academic Research Consortium (ARC) definition

    1 year

  • bleeding

    bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition

    1 year

Secondary Outcomes (1)

  • Major adverse cardiac and cerebrovascular Events (MACCE)

    1 year

Study Arms (2)

Bleeding prevention group

ACTIVE COMPARATOR

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

Drug: DAPT reductionDrug: DAPT on-target

Ischemia prevention group

ACTIVE COMPARATOR

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

Drug: DAPT on-targetDrug: DAPT intensification

Interventions

DAPT reductionDRUG

Reduction of standard dose DAPT due to low platelet reactivity

Bleeding prevention group
DAPT on-targetDRUG

Standard DAPT within the therapeutic window of platelet reactivity

Bleeding prevention groupIschemia prevention group
DAPT intensificationDRUG

Intensification of standard dose DAPT due to high platelet reactivity

Ischemia prevention group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all consecutive PCI patients

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Franz Josef Hospital

Vienna, 1100, Austria

Location

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Guenter Christ, MD

    Kaiser Franz Josef Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

AU(1)