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Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital
ClinicalTrials.gov Identifier:
NCT01515345
First received: January 18, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Platelet Inhibition
Coronary Stent Implantation
 Drug: prasugrel or ticagrelor
Drug: Clopidogrel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaiser Franz Josef Hospital:

Primary Outcome Measures:
  • Definite Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

  • Any Bleeding Event [ Time Frame: 30days ] [ Designated as safety issue: Yes ]

    Bleeding classified by the TIMI hemorrhage classification scheme:

    Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin of 3 to < 5 g/dL

    Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL



Secondary Outcome Measures:
  • Probable Stent Thrombosis [ Time Frame: 30days ] [ Designated as safety issue: No ]

    Probable stent thrombosis is considered to have occurred in case of

    1. any unexplained death within the first 30 days.
    2. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure


Enrollment: 1008
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard therapy
standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
 Drug: Clopidogrel
clopidogrel 75mg od for 12 month
Other Name: Plavix
Experimental: individualized therapy
dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
 Drug: prasugrel or ticagrelor
prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
Other Names:
  • Efient
  • Brilique

Detailed Description:

Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515345

Locations
Austria
Kaiser Franz Josef Hospital
Vienna, Austria, 1100
Sponsors and Collaborators
Kaiser Franz Josef Hospital
Investigators
Principal Investigator: Guenter Christ, MD Kaiser Franz Josef Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Dr. Guenter Christ, Univ. Prof. Dr., Kaiser Franz Josef Hospital
ClinicalTrials.gov Identifier: NCT01515345     History of Changes
Other Study ID Numbers: IDEAL-PCI protocol 1.0
Study First Received: January 18, 2012
Results First Received: February 3, 2013
Last Updated: May 13, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Kaiser Franz Josef Hospital:
clopidogrel-nonresponder
stent thrombosis

Additional relevant MeSH terms:
Clopidogrel
Prasugrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013