PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort
NCT ID: NCT01300507
Last Updated: 2013-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2011-06-30
2018-03-31
Brief Summary
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Detailed Description
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Objective: to identify novel predictors and to observe clinical outcome after an episode of ST, with the use of state-of-the-art new techniques such as OCT/IVUS, platelet function testing, genetic analysis.
Study design: multicenter matched case control study
Study population:
Cases: all patients presenting with definite ST. Expected number of patients to be included: 2000
Controls: patients undergoing PCI will be matched based on the following criteria:
Expected number of patients to be matched: 2000
1. who underwent a PCI for the same indication
2. who underwent a PCI on the same date (±5 days)
3. who underwent a PCI in the same interventional centre Main study parameters/endpoints: clinical, ECG, biochemical, angiographic, procedural, haematological, histopathological, genetic, OCT/IVUS-imaging, and follow-up characteristics Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Prior to PCI, 50 ml of whole blood will be drawn from all patients. Primary PCI for ST will be performed according to institutional best practise. During PCI, performance of Optical Coherence Tomography and/or Intravascular Ultrasound is encouraged. Thrombus aspiration is performed when indicated. During hospitalisation, all patients will be asked to fulfil a questionnaire regarding possible triggering mechanisms that might have provoked the ST. Patients will be asked to visit the patient clinic for platelet function 30 days after the acute phase of the ST. Finally, patients will be contacted for follow-up details.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Deutsches Herzzentrum Muenchen
OTHER
European Union
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Prof Dr Walter Desmet
prof. dr. W. Desmet, KULeuven, Belgium and prof. T. Gerschlick, University Hospital Leicester, UK, University Hospitals Leuven, Belgium
Principal Investigators
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Walter Desmet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiology, University Hospitals Leuven, Belgium
Tony Gershlick, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Div. of Cardiology, Glenfield Hospital, Leicester, United Kingdom
Adnan Kastrati, MD, PhD
Role: STUDY_CHAIR
German Heart Institute, Munich, Germany
Steffen Massberg, MD, PhD
Role: STUDY_CHAIR
German Heart Institute, Munich, Germany
Tom Adriaenssens, MD
Role: STUDY_DIRECTOR
Dept. of Cardiology, University Hospitals Leuven, Belgium
Wouter van Werkum, MD, PhD
Role: STUDY_DIRECTOR
Dept. of Cardiology, St Antonius Hospital Nieuwegein, the Netherlands
Locations
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UGasthuisberg
Leuven, Flemish Brabant, Belgium
Countries
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Central Contacts
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Other Identifiers
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PRESTIGE 5.0 26.01.11
Identifier Type: -
Identifier Source: org_study_id
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