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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: June 3, 2013
Last verified: June 2013
Results First Received: February 3, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Platelet Inhibition
Coronary Stent Implantation
Interventions: Drug: prasugrel or ticagrelor
Drug: Clopidogrel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution untill June 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Therapy standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
Individualized Therapy dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer

Participant Flow:   Overall Study
    Standard Therapy     Individualized Therapy  
STARTED     665     343  
COMPLETED     664     343  
NOT COMPLETED     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard Therapy standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
Individualized Therapy dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Total Total of all reporting groups

Baseline Measures
    Standard Therapy     Individualized Therapy     Total  
Number of Participants  
[units: participants]
  665     343     1008  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     333     169     502  
>=65 years     332     174     506  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 12     64  ± 12     65  ± 12  
Gender  
[units: participants]
     
Female     183     120     303  
Male     482     223     705  
Region of Enrollment  
[units: participants]
     
Austria     665     343     1008  



  Outcome Measures
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1.  Primary:   Definite Stent Thrombosis   [ Time Frame: 30 days ]

2.  Primary:   Any Bleeding Event   [ Time Frame: 30days ]

3.  Secondary:   Probable Stent Thrombosis   [ Time Frame: 30days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Univ.Prof. Dr Günter Christ
Organization: Kaiser Franz Josef Hospital
phone: +43160191 ext 2508
e-mail: guenter.christ@wienkav.at


Publications:

Responsible Party: Prof. Dr. Guenter Christ, 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: June 3, 2013
Health Authority: Austria: Ethikkommission