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NCT02974777 Clinical Trial

The IDEAL-PCI Extended Registry

Platelet Dysfunction Due to Drugs Clinical Trial

— IDEAL-PCI ext  

Official title:
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Extended Registry

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02974777
Other study ID # IDEAL-PCI v.2
Secondary ID
Status Withdrawn
Phase Phase 4
First received November 23, 2016
Last updated January 25, 2018
Est. completion date January 2017

Study information
Verified date January 2018
Source Kaiser Franz Josef Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- all consecutive PCI patients

Exclusion Criteria:

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DAPT reduction
Reduction of standard dose DAPT due to low platelet reactivity
• DAPT on-target
Standard DAPT within the therapeutic window of platelet reactivity
• DAPT intensification
Intensification of standard dose DAPT due to high platelet reactivity

Locations
Country Name City State
Austria Kaiser Franz Josef Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Kaiser Franz Josef Hospital

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary stent thrombosis stent thrombosis by any Academic Research Consortium (ARC) definition 1 year
Primary bleeding bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition 1 year
Secondary Major adverse cardiac and cerebrovascular Events (MACCE) death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization 1 year
See also
  Status Clinical Trial Phase
Completed NCT04206176 - The Effects of loW Dose tIcagrelor on Platelet Function Testing in Patients With Stable Coronary arTery Disease Phase 1/Phase 2
Completed NCT02979158 - Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass N/A
Withdrawn NCT03338660 - Platelet Function With Various Storage Techniques Phase 2
Completed NCT03603249 - Trimetazidine as an Adjunct to Enhance Clopidogrel Response. Phase 2
Completed NCT03111420 - Study of AggreGuide A-100 (ADP) Assay N/A
Recruiting NCT03005704 - Reversal of the Antiplatelet Effects of Ticagrelor in Combination With Aspirin, Using Normal Platelets N/A
Recruiting NCT06228820 - Aspirin Resistance in Trinidad. Phase 2
Completed NCT04342819 - The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study. Phase 2/Phase 3
Completed NCT03121898 - PLATelet Function Operating Room Monitoring
Active, not recruiting NCT03787927 - Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets Phase 1/Phase 2

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