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

Coronary Stent Implantation Clinical Trial

— IDEAL-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515345
• Other study ID #: IDEAL-PCI protocol 1.0
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: June 3, 2013
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Kaiser Franz Josef Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

• pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Stent Implantation
• Platelet Inhibition

Intervention

Drug:
• prasugrel or ticagrelor
prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
• Clopidogrel
clopidogrel 75mg od for 12 month

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Franz Josef Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. Erratum in: JAMA. 2011 Jun 1;305(21);2174. Stillablower, Michael E [corrected to Stillabower, Michael E]. — View Citation

Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definite Stent Thrombosis	The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"	30 days	No
Primary	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 fall in hemoglobin 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	Yes
Secondary	Probable Stent Thrombosis	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	30days	No

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