- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974777
The IDEAL-PCI Extended Registry (IDEAL-PCI ext)
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry
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
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1100
- Kaiser Franz Josef Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all consecutive PCI patients
Exclusion Criteria:
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Reduction of standard dose DAPT due to low platelet reactivity
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
|
Standard DAPT within the therapeutic window of platelet reactivity
Intensification of standard dose DAPT due to high platelet reactivity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stent thrombosis
Time Frame: 1 year
|
stent thrombosis by any Academic Research Consortium (ARC) definition
|
1 year
|
bleeding
Time Frame: 1 year
|
bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac and cerebrovascular Events (MACCE)
Time Frame: 1 year
|
death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guenter Christ, MD, Kaiser Franz Josef Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDEAL-PCI v.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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