Back to resultsThe IDEAL-PCI Extended Registry (IDEAL-PCI ext)
Primary Purpose
Coronary Arterioscleroses, Platelet Dysfunction Due to Drugs
Status
Withdrawn
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
DAPT reduction
DAPT on-target
DAPT intensification
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Arterioscleroses
Eligibility Criteria
Inclusion Criteria:
- all consecutive PCI patients
Exclusion Criteria:
- pregnancy
Sites / Locations
- Kaiser Franz Josef Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bleeding prevention group
Ischemia prevention group
Arm Description
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Outcomes
Primary Outcome Measures
stent thrombosis
stent thrombosis by any Academic Research Consortium (ARC) definition
bleeding
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
Secondary Outcome Measures
Major adverse cardiac and cerebrovascular Events (MACCE)
death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization
Full Information
NCT ID
NCT02974777
First Posted
November 23, 2016
Last Updated
January 25, 2018
Sponsor
Kaiser Franz Josef Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02974777
Brief Title
The IDEAL-PCI Extended Registry
Acronym
IDEAL-PCI ext
Official Title
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
not started due to regulatory reasons
Study Start Date
undefined (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Franz Josef Hospital
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arterioscleroses, Platelet Dysfunction Due to Drugs
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bleeding prevention group
Arm Type
Active Comparator
Arm Description
Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor
Arm Title
Ischemia prevention group
Arm Type
Active Comparator
Arm Description
Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor
Intervention Type
Drug
Intervention Name(s)
DAPT reduction
Intervention Description
Reduction of standard dose DAPT due to low platelet reactivity
Intervention Type
Drug
Intervention Name(s)
DAPT on-target
Intervention Description
Standard DAPT within the therapeutic window of platelet reactivity
Intervention Type
Drug
Intervention Name(s)
DAPT intensification
Intervention Description
Intensification of standard dose DAPT due to high platelet reactivity
Primary Outcome Measure Information:
Title
stent thrombosis
Description
stent thrombosis by any Academic Research Consortium (ARC) definition
Time Frame
1 year
Title
bleeding
Description
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular Events (MACCE)
Description
death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all consecutive PCI patients
Exclusion Criteria:
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenter Christ, MD
Organizational Affiliation
Kaiser Franz Josef Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Franz Josef Hospital
City
Vienna
ZIP/Postal Code
1100
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01515345
Description
IDEAL-PCI Registry
Learn more about this trial
The IDEAL-PCI Extended Registry
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