Aortic StenosisTAVINCT02504632
Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation
A study testing test in people with Aortic Stenosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Test group
- Severe symptomatic AS (Aortic valve area < 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis.
- Aspirin treatment (75-160 mg/d for at least one week)
- Control group
- Stable coronary artery disease, unscathed of AS
- Aspirin treatment (75-160 mg/d for at least one week)
Who cannot join
- Test group:
- Acute coronary syndrome 1 month before inclusion
- Any co-morbidity limiting life-expectancy < 1 year
- Terminal chronic kidney disease requiring hemodialysis thrombocytopenia <100 G/L, anemia (Hb < 10 g/dl)
- Treatment by another antiplatelet agent within 10 days before the procedure
- Control group:
Show all 11Show fewer
- Acute coronary syndrome 1 month before inclusion
- Any co-morbidity limiting life-expectancy < 1 year
- Terminal chronic kidney disease requiring hemodialysis
- Thrombocytopenia <100 G/L
- Treatment by another antiplatelet agent within 10 days before the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI
Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)
Read the detailed description
- Background: TAVI has emerged as an alternative to surgical aortic valve replacement for patients with severe, symptomatic aortic stenosis (AS) and is expanding worldwide with more than 50,000 patients treated to date.
- Purpose Changes in haemostasis, particularly in platelet activation or reactivity before, during and after TAVI have never been studied. Valve replacement is known to alleviate von Willebrand factor abnormalities associated with AS. A potential improvement of platelet function could also occur after TAVI. Indeed, circulating platelets may be desensitized and under-reactive due to multiple passages through the stenotic valve and could recover normal reactivity after TAVI. Besides, TAVI presents a risk of major ischemic complications. The investigators can hypothesize the involvement of high reactive platelets in peri-procedural thrombotic or ischemic events. This study of the platelet activation kinetics will be performed by comparing several specific markers before and at various times after valve implantation.
- Primary outcome To evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at days 1 and 5±1 after the procedure.
- Study design and number of subjects: This is a prospective, monocentric, study. The test group includes up to 15 patients treated by transfemoral TAVI using a MedTronic CoreValve (MCV) prosthesis. Platelet activation will be studied before and after the procedure and compared to a reference established with an age-matched, aspirin-treated, atherosclerotic population (30 patients in the control group).
- Eligibility criteria:
- inclusion criteria: test group: patients with severe aortic stenosis and transfemoral TAVI with MCV aspirin treatment . Control group: age-matched patients with stable coronary artery disease treated by aspirin but without aortic stenosis.
- exclusion criteria: recent (1 month) acute coronary syndrome; treatment by anti platelet agents other than aspirin
- Procedures: Specific platelet activation markers, circulating platelet/monocytes aggregates, platelet reactivity and vWF will be assessed in peripheral venous blood before, 1 and 5 days after TAVI and in ascending aorta during the procedure.
- Conditions
- Aortic Stenosis
- Being tested
- test, control group
- Keywords
- platelet activation, transcatheter aortic valve implantation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testOther
Peripheral venous citrated blood will be collected just before and 10-15 min after the implantation of the valve. Samples will be obtained after starting the infusion of contrast media. In peripheral venous blood before 24 h and after the procedure and at hospital discharge, 4-6 days when the usual transient thrombocytopenia after TAVI has recovered.
The results will be used to analyse the kinetics of haematological changes in peripheral blood following aortic valve replacement.
Platelet activation will be monitored by flow cytometry to assess the expression of specific membrane markers and the phosphorylation of signalling proteins, as well as the formation of platelet/monocyte aggregates.
control groupOther
In this group, only one sample (2 tubes filled with 4.5 ml, i.e. 9ml) will be obtained in venous peripheral blood to establish reference values in age-matched, aspirin-treated, atherosclerotic population.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Patient with severe, symptomatic AS (Aortic valve area < 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis. Receives: Other: test |
| control group | Other | Patient with stable coronary artery disease, unscathed of AS Patient under aspirin treatment (75-160 mg/d for at least one week) Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of kinetics of platelet activation
Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at day 1 after the procedure using flow cytometry (FACS).
Measured: 1 min before TAVI and at days 1after TAVI
the change of kinetics of platelet activation
Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at 5±1 days after the procedure using flow cytometry (FACS).
Measured: 1 min before TAVI and 5±1 after TAVI
Secondary outcomes (4)
Changes of platelet activation
platelet activation in aortic blood downstream of the stenotic valve before and 10 min after TAVI,
Measured: 1 min before and 10 min after TAVI
Changes of platelet activity
platelet reactivity to selected agonists in peripheral venous blood samples before and at days 1 and 5±1. Measure of platelet/monocytes aggregates by flow cytometry approaches. Measure of plasma serotonin and soluble GPIV by an by an ELISA technique
Measured: 1 min before and day 1 after TAVI
Changes of platelet activity
platelet reactivity to selected agonists in peripheral venous blood samples before and at days 1 and 5±1,
Measured: 1 min before and day 5 after TAVI
changes in von Willebrand factor
changes in von Willebrand factor in peripheral blood samples The activity and level of vWF antigen will be measured by immunotubidimetric methods
Measured: 1 min before and day 1 and 5 after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Pierre SIE, MD PhD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504632
- Sponsor's protocol ID
- 14 7078 03
- Acronym
- TAVI
- Status last verified
- Mar 2017
- First submitted
- 17 Jul 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI
- ClinicalTrials.gov ID
- NCT02504632
- Acronym / sponsor ID
- TAVI / 14 7078 03
- Conditions
- Aortic Stenosis
- Keywords
- platelet activation, transcatheter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Jul 2015 (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.
Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)
Detailed description
- Background: TAVI has emerged as an alternative to surgical aortic valve replacement for patients with severe, symptomatic aortic stenosis (AS) and is expanding worldwide with more than 50,000 patients treated to date.
- Purpose Changes in haemostasis, particularly in platelet activation or reactivity before, during and after TAVI have never been studied. Valve replacement is known to alleviate von Willebrand factor abnormalities associated with AS. A potential improvement of platelet function could also occur after TAVI. Indeed, circulating platelets may be desensitized and under-reactive due to multiple passages through the stenotic valve and could recover normal reactivity after TAVI. Besides, TAVI presents a risk of major ischemic complications. The investigators can hypothesize the involvement of high reactive platelets in peri-procedural thrombotic or ischemic events. This study of the platelet activation kinetics will be performed by comparing several specific markers before and at various times after valve implantation.
- Primary outcome To evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at days 1 and 5±1 after the procedure.
- Study design and number of subjects: This is a prospective, monocentric, study. The test group includes up to 15 patients treated by transfemoral TAVI using a MedTronic CoreValve (MCV) prosthesis. Platelet activation will be studied before and after the procedure and compared to a reference established with an age-matched, aspirin-treated, atherosclerotic population (30 patients in the control group).
- Eligibility criteria:
- inclusion criteria: test group: patients with severe aortic stenosis and transfemoral TAVI with MCV aspirin treatment . Control group: age-matched patients with stable coronary artery disease treated by aspirin but without aortic stenosis.
- exclusion criteria: recent (1 month) acute coronary syndrome; treatment by anti platelet agents other than aspirin
- Procedures: Specific platelet activation markers, circulating platelet/monocytes aggregates, platelet reactivity and vWF will be assessed in peripheral venous blood before, 1 and 5 days after TAVI and in ascending aorta during the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Other: testPatient with severe, symptomatic AS (Aortic valve area < 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis. |
| control group | Other | Other: control groupPatient with stable coronary artery disease, unscathed of AS Patient under aspirin treatment (75-160 mg/d for at least one week) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Test group
- Control group
Key exclusion criteria (11 listed)
- Test group:
- Control group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testPeripheral venous citrated blood will be collected just before and 10-15 min after the implantation of the valve. Samples will be obtained after starting the infusion of contrast media. In peripheral venous blood before 24 h and after the procedure and at hospital discharge, 4-6 days when the usual transient thrombocytopenia after TAVI has recovered. The results will be used to analyse the kinetics of haematological changes in peripheral blood following aortic valve replacement. Platelet activation will be monitored by flow cytometry to assess the expression of specific membrane markers and the phosphorylation of signalling proteins, as well as the formation of platelet/monocyte aggregates. | Other | test group |
| control groupIn this group, only one sample (2 tubes filled with 4.5 ml, i.e. 9ml) will be obtained in venous peripheral blood to establish reference values in age-matched, aspirin-treated, atherosclerotic population. | Other | control group |
Primary outcome
the change of kinetics of platelet activation
Time frame: 1 min before TAVI and at days 1after TAVI
Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at day 1 after the procedure using flow cytometry (FACS).
the change of kinetics of platelet activation
Time frame: 1 min before TAVI and 5±1 after TAVI
Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at 5±1 days after the procedure using flow cytometry (FACS).
4 secondary outcomes
Changes of platelet activation
Time frame: 1 min before and 10 min after TAVI
Changes of platelet activity
Time frame: 1 min before and day 1 after TAVI
Changes of platelet activity
Time frame: 1 min before and day 5 after TAVI
changes in von Willebrand factor
Time frame: 1 min before and day 1 and 5 after TAVI
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 14 Mar 2017.
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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.
Pierre SIE, MD PhD study chair
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test in people with Aortic Stenosis, run by University Hospital, Toulouse 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 6 inclusion and 11 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 14 Mar 2017. 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?
the change of kinetics of platelet activation (time frame: 1 min before TAVI and at days 1after TAVI). The study lists 2 primary outcomes in all. 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 14 Mar 2017.