IDEAL-PCI ext: The IDEAL-PCI Extended Registry

• Sponsor: Kaiser Franz Josef Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02974777
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Arterioscleroses; Platelet Dysfunction Due to Drugs	Drug: DAPT reduction; Drug: DAPT on-target; Drug: DAPT intensification	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bleeding prevention group Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor	Drug: DAPT reduction; Reduction of standard dose DAPT due to low platelet reactivity; Drug: DAPT on-target; Standard DAPT within the therapeutic window of platelet reactivity
Active Comparator: Ischemia prevention group Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor	Drug: DAPT on-target; Standard DAPT within the therapeutic window of platelet reactivity; Drug: DAPT intensification; Intensification of standard dose DAPT due to high platelet reactivity

Outcome Measures

Primary Outcome Measures

1. stent thrombosis [1 year]

   stent thrombosis by any Academic Research Consortium (ARC) definition

2. bleeding [1 year]

   bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition

Secondary Outcome Measures

1. Major adverse cardiac and cerebrovascular Events (MACCE) [1 year]

   death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all consecutive PCI patients

Exclusion Criteria:

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Franz Josef Hospital	Vienna		Austria	1100

Sponsors and Collaborators

• Kaiser Franz Josef Hospital

Investigators

• Principal Investigator: Guenter Christ, MD, Kaiser Franz Josef Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• IDEAL-PCI Registry

Publications

None provided.

• Responsible Party: Prof. Dr. Guenter Christ, Prof, Kaiser Franz Josef Hospital
• ClinicalTrials.gov Identifier: NCT02974777
• Other Study ID Numbers: IDEAL-PCI v.2
• First Posted: Nov 28, 2016
• Last Update Posted: Jan 26, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Jan 26, 2018