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

NCT01515345 | Completed Phase 3 Results

• 1 other identifier: IDEAL-PCI protocol 1.0
• Study Type: interventional
• Target: 1,008
• Locations: 1 country
• Sites: 1

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).

Conditions

Platelet Inhibition; Coronary Stent Implantation

Keywords

clopidogrel-nonresponder; stent thrombosis

Outcome Measures

Primary Outcomes (2)

• Definite Stent Thrombosis

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

  30 days

• Any Bleeding Event

  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

  30days

Secondary Outcomes (1)

• Probable Stent Thrombosis

  30days

Study Arms (2)

standard therapy

ACTIVE COMPARATOR

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

Drug: Clopidogrel

individualized therapy

EXPERIMENTAL

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

Drug: prasugrel or ticagrelor

Interventions

prasugrel or ticagrelor DRUG

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

Also known as: Efient, Brilique

individualized therapy

Clopidogrel DRUG

clopidogrel 75mg od for 12 month

Also known as: Plavix

standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all consecutive PCI patients with stent implantation of our institution

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Kaiser Franz Josef Hospital: lead

Study Sites (1)

Kaiser Franz Josef Hospital

Vienna, Vienna, 1100, Austria

Location

Related Publications (4)

• 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.

  PMID: 19264241 BACKGROUND

• 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.

  PMID: 18387444 BACKGROUND

• 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.

  PMID: 21406646 BACKGROUND

• 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.

  PMID: 25361837 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Prasugrel Hydrochloride; Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Pyridines

Results Point of Contact

• Title: Univ.Prof. Dr Günter Christ
• Organization: Kaiser Franz Josef Hospital

guenter.christ@wienkav.at

+43160191

Study Officials

• Guenter Christ, MD

  Kaiser Franz Josef Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 24, 2012
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 25, 2017
• Results First Posted: May 1, 2013

Record last verified: 2017-03

Locations

AU (1)