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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515345
First Posted: January 24, 2012
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital:

Primary Outcome Measures:
  • Definite Stent Thrombosis [ Time Frame: 30 days ]
    The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

  • Any Bleeding Event [ Time Frame: 30days ]

    Bleeding classified by the TIMI hemorrhage classification scheme:

    Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop 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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 18, 2012
First Posted: January 24, 2012
Results First Submitted: February 3, 2013
Results First Posted: May 1, 2013
Last Update Posted: April 25, 2017
Last Verified: March 2017

Keywords provided by Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital:
clopidogrel-nonresponder
stent thrombosis

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Prasugrel Hydrochloride
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors