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

Phase 3

Completed

• Conditions: Platelet Inhibition; Coronary Stent Implantation
• Interventions: Drug: Clopidogrel; Drug: prasugrel or ticagrelor

• Registration Number: NCT01515345
• Lead Sponsor: Kaiser Franz Josef Hospital

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).

Detailed 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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2013-02-03
• Results First Submitted QC: 2013-03-19
• Results First Posted: 2013-05-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1008

Inclusion Criteria

• all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard therapy	Clopidogrel	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
individualized therapy	prasugrel or ticagrelor	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer

Primary Outcome Measures

Name	Time	Method
Definite Stent Thrombosis	30 days	The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
Any Bleeding Event	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 Outcome Measures

Name	Time	Method
Probable Stent Thrombosis	30days	Probable stent thrombosis is considered to have occurred in case of; 1. any unexplained death within the first 30 days.; 2. 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

Trial Locations

Locations (1)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria