Clinical trial NCT01300507: PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort
Official title: PREvention of Stent Thrombosis by an Interdisciplinary Global
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Stent Thrombosis
Keywords: stent thrombosis
intra coronary imaging
blood platelet function testing
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Deutsches Herzzentrum Muenchen
name: European Union
First posted: 2011-02-21
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Detailed description: 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

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.

Eligibility criteria: Inclusion Criteria:

* patients presenting with stent thrombosis

Exclusion Criteria:

* patients refusing informed consent

Primary outcomes:
measure: to identify novel factors responsible for the occurence of stent thrombosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UGasthuisberg
state: Flemish Brabant
Study officials:
affiliation: Dept. of Cardiology, University Hospitals Leuven, Belgium
name: Walter Desmet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Div. of Cardiology, Glenfield Hospital, Leicester, United Kingdom
name: Tony Gershlick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Heart Institute, Munich, Germany
name: Adnan Kastrati, MD, PhD
role: STUDY_CHAIR
affiliation: German Heart Institute, Munich, Germany
name: Steffen Massberg, MD, PhD
role: STUDY_CHAIR
affiliation: Dept. of Cardiology, University Hospitals Leuven, Belgium
name: Tom Adriaenssens, MD
role: STUDY_DIRECTOR
affiliation: Dept. of Cardiology, St Antonius Hospital Nieuwegein, the Netherlands
name: Wouter van Werkum, MD, PhD
role: STUDY_DIRECTOR
References: