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

January 18, 2012
June 3, 2013
July 2011
January 2013   (final data collection date for primary outcome measure)
  • 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

  • early definite stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    early (= acute and subacute) definite stent thrombosis according to ARC criteria
  • any bleeding event [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
    bleeding classified by the TIMI hemorrhage classification scheme
Complete list of historical versions of study NCT01515345 on ClinicalTrials.gov Archive Site
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
probable stent thrombosis [ Time Frame: 30days ] [ Designated as safety issue: No ]
probable stent thrombosis according to ARC criteria, which includes also sudden death
Not Provided
Not Provided
 
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI 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).

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Platelet Inhibition
  • Coronary Stent Implantation
  • Drug: prasugrel or ticagrelor
    prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
    Other Names:
    • Efient
    • Brilique
  • Drug: Clopidogrel
    clopidogrel 75mg od for 12 month
    Other Name: Plavix
  • Active Comparator: standard therapy
    standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
    Intervention: Drug: Clopidogrel
  • Experimental: individualized therapy
    dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
    Intervention: Drug: prasugrel or ticagrelor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1008
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01515345
IDEAL-PCI protocol 1.0
No
Prof. Dr. Guenter Christ, Kaiser Franz Josef Hospital
Kaiser Franz Josef Hospital
Not Provided
Principal Investigator: Guenter Christ, MD Kaiser Franz Josef Hospital
Kaiser Franz Josef Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP