PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort (PRESTIGE)
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|ClinicalTrials.gov Identifier: NCT01300507|
Recruitment Status : Unknown
Verified January 2013 by Prof Dr Walter Desmet, University Hospital, Gasthuisberg.
Recruitment status was: Recruiting
First Posted : February 21, 2011
Last Update Posted : January 18, 2013
|Condition or disease|
|Coronary Artery Stent Thrombosis|
Rationale: Stent Thrombosis (ST) is a serious complication of percutaneous coronary intervention (PCI) with stent implantation. Previous studies have been hampered by small sample size, in particular regarding the number of patients with late and very late ST and patients with DES thrombosis, and by incomplete patient characterisation, particularly concerning intracoronary imaging and blood platelet function data.
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
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
- who underwent a PCI for the same indication
- who underwent a PCI on the same date (±5 days)
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Observational Model:||Case Control|
|Official Title:||PREvention of Stent Thrombosis by an Interdisciplinary Global|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2018|
- to identify novel factors responsible for the occurence of stent thrombosis [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
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): NCT01300507
|Contact: Walter Desmet, MD, PhD||+32 16 34 24 firstname.lastname@example.org|
|Contact: Adnan Kastrati, MD, PhD||+49 (0) 89 1218-4073||Kastrati@dhm.mhn.de|
|Leuven, Flemish Brabant, Belgium, 3000|
|Sub-Investigator: Tom Adriaenssens, MD|
|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|