Stent ThrombosisVERIFRENCHYNCT00753753
VerifyNow French Registry
An observational study of Stent Thrombosis and Clopidogrel, run by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres at 1 site in France.
Trial summary
The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as measured by a point-of-care platelet function assay on thrombotic or bleeding events after percutaneous coronary intervention (PCI) with drug eluting or bare metal stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Thrombosis, Clopidogrel, Aspirin
- How many people
- 1,001 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Nov 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: real world patient referred for coronary angioplasty with stent
Who may be able to join
- Coronary angioplasty with stent
Who cannot join
- Use of AGP2b3a
- Acute myocardial infarction
- No aspirin and clopidogrel pretreatment
- Use of AVK
- Aspirin or clopidogrel contre-indication
Trial locations and contacts
1 site in 1 country.
France1 site
cardiology unit / Les hopitaux de Chartres
Chartres, Eure Et Loir, 28000
About this study
Official title: Evaluation of the Occurence of Thrombotic and Bleeding Events After Coronary Angioplasty With Stent According to Aspirin and Clopidogrel Platelet Reactivity Assessed by a Point of Care Assay in the Cathlab (the Verifynow French Registry)
The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as measured by a point-of-care platelet function assay on thrombotic or bleeding events after percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.
Methods:
Read more
Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive patients from 20 centers in France undergoing coronary angioplasty with stent.
Exclusion criteria are:
Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off : < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of definite or probable stent thrombosis (ARC definition) and the secondary end-points include global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A clinical evaluation is scheduled at discharge and by telephone contact at one month and one year.
- Conditions
- Stent Thrombosis, Clopidogrel, Aspirin, Bleeding, Angioplasty
- Keywords
- stent thrombosis, clopidogrel, aspirin, bleeding, coronary, angioplasty
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent thrombosis
Measured: one year
Secondary outcomes (1)
Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stent ThrombosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Boston Scientific Corporation, Cordis US Corp., Abbott
- Responsible party
- Principal investigator, RANGE Gregoire, Association Pour le Développement des Soins Cardiologiques de la ville de Chartres
- Investigators
- gregoire rangé, Principal investigator, GACI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753753
- Sponsor's protocol ID
- VERIfynow FRENCH registrY
- Other IDs
- CPP n°2008-N2, AFFSAPS 2008-A00411-54
- Acronym
- VERIFRENCHY
- Status last verified
- Jun 2015
- First submitted
- 15 Sep 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Range G, Yayehd K, Belle L, Thuaire C, Richard P, Cazaux P, Barbou F, Koning R, Chassaing S, Teiger E, Berthier R, Decomis MP, Claudel JP, Delarche N, Brunel P, De Poli F, Dupouy P, Beygui F, Albert F, Collet JP, Montalescot G; VERIFRENCHY investigators. Thrombotic and bleeding events after coronary stenting according to clopidogrel and aspirin platelet reactivity: VerifyNow French Registry (VERIFRENCHY). Arch Cardiovasc Dis. 2014 Apr;107(4):225-35. doi: 10.1016/j.acvd.2014.03.004. Epub 2014 Apr 29.
PubMed 24794216
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Occurence of Thrombotic and Bleeding Events After Coronary Angioplasty With Stent According to Aspirin and Clopidogrel Platelet Reactivity Assessed by a Point of Care Assay in the Cathlab (the Verifynow French Registry)
- ClinicalTrials.gov ID
- NCT00753753
- Acronym / sponsor ID
- VERIFRENCHY / VERIfynow FRENCH registrY
- Conditions
- Stent Thrombosis, Clopidogrel, Aspirin, Bleeding, Angioplasty
- Keywords
- stent thrombosis, clopidogrel, aspirin, bleeding, coronary, angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Association Pour le Développement des Soins Cardiologiques de la ville de ChartresUniversity, hospital or other
- Collaborators
- Medtronic, Boston Scientific Corporation, Cordis US Corp., Abbott
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Sep 2008 (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 purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as measured by a point-of-care platelet function assay on thrombotic or bleeding events after percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.
Methods:
Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive patients from 20 centers in France undergoing coronary angioplasty with stent.
Exclusion criteria are:
Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off : < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of definite or probable stent thrombosis (ARC definition) and the secondary end-points include global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A clinical evaluation is scheduled at discharge and by telephone contact at one month and one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- real world patient referred for coronary angioplasty with stent
Key inclusion criteria (1 listed)
- Coronary angioplasty with stent
Key exclusion criteria (5 listed)
- Use of AGP2b3a
- Acute myocardial infarction
- No aspirin and clopidogrel pretreatment
- Use of AVK
- Aspirin or clopidogrel contre-indication
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
Stent thrombosis
Time frame: one year
1 secondary outcome
Mortality, cardio-vascular mortality, non fatal Myocardial infarction, urgent coronary revascularisation , re-hospitalization, severe bleeding
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Derived from this study: PubMed 24794216Range G, Yayehd K, Belle L, Thuaire C, Richard P, Cazaux P, Barbou F, Koning R, Chassaing S, Teiger E, Berthier R, Decomis MP, Claudel JP, Delarche N, Brunel P, De Poli F, Dupouy P, Beygui F, Albert F, Collet JP, Montalescot G; VERIFRENCHY investigators. Thrombotic and bleeding events after coronary stenting according to clopidogrel and aspirin platelet reactivity: VerifyNow French Registry (VERIFRENCHY). Arch Cardiovasc Dis. 2014 Apr;107(4):225-35. doi: 10.1016/j.acvd.2014.03.004. Epub 2014 Apr 29.
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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.
gregoire rangé principal investigator
GACI
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 Stent Thrombosis and Clopidogrel, run by Association Pour le Développement des Soins Cardiologiques de la ville de Chartres at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 25 Jun 2015. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent thrombosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753753, which also lists 1 linked publication.
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 25 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.