Coronary Artery Stent ThrombosisPRESTIGENCT01300507
PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort
An observational study of Coronary Artery Stent Thrombosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Stent Thrombosis
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- patients presenting with stent thrombosis
Who cannot join
- patients refusing informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UGasthuisberg
Leuven, Flemish Brabant, 3000
Tom Adriaenssens, MD
About this study
Official title: PREvention of Stent Thrombosis by an Interdisciplinary Global
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.
Read the 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
- 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.
- Conditions
- Coronary Artery Stent Thrombosis
- Keywords
- stent thrombosis, intra coronary imaging, blood platelet function testing
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify novel factors responsible for the occurence of stent thrombosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2015 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Stent ThrombosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Herzzentrum Muenchen, European Union
- Responsible party
- Principal investigator, Prof Dr Walter Desmet, University Hospital, Gasthuisberg
- Investigators
- Walter Desmet, MD, PhD, Principal investigator, Dept. of Cardiology, University Hospitals Leuven, BelgiumTony Gershlick, MD, PhD, Principal investigator, Div. of Cardiology, Glenfield Hospital, Leicester, United KingdomAdnan Kastrati, MD, PhD, Study chair, German Heart Institute, Munich, GermanySteffen Massberg, MD, PhD, Study chair, German Heart Institute, Munich, GermanyTom Adriaenssens, MD, Study director, Dept. of Cardiology, University Hospitals Leuven, BelgiumWouter van Werkum, MD, PhD, Study director, Dept. of Cardiology, St Antonius Hospital Nieuwegein, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300507
- Sponsor's protocol ID
- PRESTIGE 5.0 26.01.11
- Acronym
- PRESTIGE
- Status last verified
- Jan 2013
- First submitted
- 18 Feb 2011
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREvention of Stent Thrombosis by an Interdisciplinary Global
- ClinicalTrials.gov ID
- NCT01300507
- Acronym / sponsor ID
- PRESTIGE / PRESTIGE 5.0 26.01.11
- Conditions
- Coronary Artery Stent Thrombosis
- Keywords
- stent thrombosis, intra coronary imaging, blood platelet function testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Deutsches Herzzentrum Muenchen, European Union
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients presenting with stent thrombosis
Key exclusion criteria (1 listed)
- patients refusing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to identify novel factors responsible for the occurence of stent thrombosis
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Desmet, MD, PhD principal investigator
Dept. of Cardiology, University Hospitals Leuven, Belgium
Tony Gershlick, MD, PhD principal investigator
Div. of Cardiology, Glenfield Hospital, Leicester, United Kingdom
Adnan Kastrati, MD, PhD study chair
German Heart Institute, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stent Thrombosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Desmet, MD, PhD (+32 16 34 24 66, sic@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to identify novel factors responsible for the occurence of stent thrombosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.