Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01300507 |
| Other study ID # |
PRESTIGE 5.0 26.01.11 |
| Secondary ID |
|
| 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.
