PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort

NCT ID: NCT01300507

Last Updated: 2013-01-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Stent Thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients presenting with stent thrombosis

Exclusion Criteria

* patients refusing informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Walter Desmet, MD, PhD

Role: CONTACT

+32 16 34 24 66

Adnan Kastrati, MD, PhD

Role: CONTACT

+49 (0) 89 1218-4073

Other Identifiers

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PRESTIGE 5.0 26.01.11

Identifier Type: -

Identifier Source: org_study_id

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