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

NCT ID: NCT01515345

Last Updated: 2017-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1008 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-01-31

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).

Detailed Description

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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.

Conditions

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Platelet Inhibition Coronary Stent Implantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard therapy

standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

clopidogrel 75mg od for 12 month

individualized therapy

dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer

Group Type EXPERIMENTAL

prasugrel or ticagrelor

Intervention Type DRUG

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

Interventions

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prasugrel or ticagrelor

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

Intervention Type DRUG

Clopidogrel

clopidogrel 75mg od for 12 month

Intervention Type DRUG

Other Intervention Names

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Efient Brilique Plavix

Eligibility Criteria

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Inclusion Criteria

* all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 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

Univ. Prof. Dr.

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, Vienna, Austria

Site Status

Countries

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Austria

References

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Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.

Reference Type BACKGROUND
PMID: 19264241 (View on PubMed)

Bonello L, Camoin-Jau L, Arques S, Boyer C, Panagides D, Wittenberg O, Simeoni MC, Barragan P, Dignat-George F, Paganelli F. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008 Apr 8;51(14):1404-11. doi: 10.1016/j.jacc.2007.12.044.

Reference Type BACKGROUND
PMID: 18387444 (View on PubMed)

Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.

Reference Type BACKGROUND
PMID: 21406646 (View on PubMed)

Christ G, Siller-Matula JM, Francesconi M, Dechant C, Grohs K, Podczeck-Schweighofer A. Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry. BMJ Open. 2014 Oct 31;4(10):e005781. doi: 10.1136/bmjopen-2014-005781.

Reference Type DERIVED
PMID: 25361837 (View on PubMed)

Related Links

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Other Identifiers

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IDEAL-PCI protocol 1.0

Identifier Type: -

Identifier Source: org_study_id

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