The IDEAL-PCI Extended Registry

Phase 4

Withdrawn

• Conditions: Coronary Arterioscleroses; Platelet Dysfunction Due to Drugs
• Interventions: Drug: DAPT reduction; Drug: DAPT on-target; Drug: DAPT intensification

• Registration Number: NCT02974777
• 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).

IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

Detailed Description

Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.

In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.

Study Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-28
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• all consecutive PCI patients

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bleeding prevention group	DAPT reduction	Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Bleeding prevention group	DAPT on-target	Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Ischemia prevention group	DAPT on-target	Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Ischemia prevention group	DAPT intensification	Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor

Primary Outcome Measures

Name	Time	Method
stent thrombosis	1 year	stent thrombosis by any Academic Research Consortium (ARC) definition
bleeding	1 year	bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular Events (MACCE)	1 year	death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization

Trial Locations

Locations (1)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria