PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort
PRESTIGE
PREvention of Stent Thrombosis by an Interdisciplinary Global
1 other identifier
observational
2,000
1 country
1
Brief Summary
The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data regarding patients presenting with stent thrombosis in a dedicated database. There will be extensive clinical and procedural characterization, furthermore blood platelet function testing, intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJanuary 18, 2013
January 1, 2013
3.8 years
February 18, 2011
January 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to identify novel factors responsible for the occurence of stent thrombosis
3 years
Eligibility Criteria
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
You may qualify if:
- patients presenting with stent thrombosis
You may not qualify if:
- patients refusing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- Deutsches Herzzentrum Muenchencollaborator
- European Unioncollaborator
Study Sites (1)
UGasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
Biospecimen
Biospecimen: 1, thrombusaspiration from coronary arteries, storage and analysis at the German Heart Center Munich; 2, DNA-samples: storage at German Heart Center Munich, Antonius Hospital Nieuwegein, The Netherlands, University Hospitals Leuven Belgium and University Hospital Leicester, UK
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Desmet, MD, PhD
Dept. of Cardiology, University Hospitals Leuven, Belgium
- PRINCIPAL INVESTIGATOR
Tony Gershlick, MD, PhD
Div. of Cardiology, Glenfield Hospital, Leicester, United Kingdom
- STUDY CHAIR
Adnan Kastrati, MD, PhD
German Heart Institute, Munich, Germany
- STUDY CHAIR
Steffen Massberg, MD, PhD
German Heart Institute, Munich, Germany
- STUDY DIRECTOR
Tom Adriaenssens, MD
Dept. of Cardiology, University Hospitals Leuven, Belgium
- STUDY DIRECTOR
Wouter van Werkum, MD, PhD
Dept. of Cardiology, St Antonius Hospital Nieuwegein, the Netherlands
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr. W. Desmet, KULeuven, Belgium and prof. T. Gerschlick, University Hospital Leicester, UK, University Hospitals Leuven, Belgium
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 21, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2018
Last Updated
January 18, 2013
Record last verified: 2013-01