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

Coronary Artery Stent Thrombosis Clinical Trial

— PRESTIGE  

Official title:

PREvention of Stent Thrombosis by an Interdisciplinary Global

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01300507
• Other study ID #: PRESTIGE 5.0 26.01.11
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2011
• Last updated: January 17, 2013
• Start date: June 2011
• Est. completion date: March 2018

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Walter Desmet, MD, PhD
• Phone: +32 16 34 24 66
• Email: sic[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2018
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients presenting with stent thrombosis

Exclusion Criteria:

• patients refusing informed consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Stent Thrombosis
• Thrombosis

Locations

Country	Name	City	State
Belgium	UGasthuisberg	Leuven	Flemish Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Deutsches Herzzentrum Muenchen, European Union

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to identify novel factors responsible for the occurence of stent thrombosis		3 years	No