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Completed

NCT Number: NCT01515345

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

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Key information

Conditions

Platelet Inhibition Coronary Stent Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Franz Josef Hospital

Vienna, State of Vienna, 1100, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consecutive PCI patients with stent implantation of our institution

Exclusion criteria

  • pregnancy

Treatment and study plan

prasugrel or ticagrelor

Drug

prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month

Other names: Efient, Brilique

clopidogrel

Drug

clopidogrel 75mg od for 12 month

Other names: Plavix

Primary outcomes

  1. Definite Stent Thrombosis

    Time frame: 30 days

    The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

  2. Any Bleeding Event

    Time frame: 30days

    Bleeding classified by the TIMI hemorrhage classification scheme:

    Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL

    Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL

Secondary outcomes

  1. Probable Stent Thrombosis

    Time frame: 30days

    Probable stent thrombosis is considered to have occurred in case of

    • any unexplained death within the first 30 days.
    • any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure

Sponsors and collaborators

Lead sponsor

Kaiser Franz Josef Hospital

Other

Registry information

Acronym: IDEAL-PCI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2012
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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