Aortic StenosisSTARTNCT03847948
Biological Factors Associated With Subclinical Valvular Thrombosis
An observational study of Aortic Stenosis, run by Hospital San Carlos, Madrid at 2 sites in Spain.
Trial summary
A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI). The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- CT SCAN
- How many people
- 166 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2018to 28 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
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: Patients with severe symptomatic aortic stenosis treated with TAVI
Who may be able to join
- Patients with severe symptomatic aortic stenosis who it was accepted to be treated with TAVI by a multidisciplinary team "Heat Team".
- TAVI was successfully implanted (according to Valve Academic Research Consortium II criteria) and are under treatment with double antiplatelet therapy.
- Signed informed consent to participate in this study.
Who cannot join
- Age under 18 years and pregnant or of childbearing age.
- Acute Recent stroke recent <14 days before TAVI.
- The patients with proven allergy to aspirin, clopidogrel
- Patients that after TAVI cannot undergo a double antiplatelet regimen for 6 months due to a new post-TAVI medical indication or are anticoagulated.
- Knowledge of pregnancy or lactation Thrombocytopenia (<50,000 platelets U / L) well documented and clinically relevant.
- The patients with documented moderate or severe hepatic insufficiency
- Severe chronic renal insufficiency with creatinine clearance <30 ml / min.
- The patients who can not attend the follow-up visits scheduled in the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial
A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).
- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography
Read the detailed description
For the purpose of the study, platelet reactivity will be measured with the commercial kit PLT VASP/P2Y12 at baseline, 1day and 3 months postprocedure.
Secondary objectives include: -Determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up.
- To determine whether the pro-thrombotic inflammatory response measured by the CD14 + and CD16 + quantification observed after TAVI is associated with the appearance of prosthetic thrombosis.
- To evaluate the Correlation of Von Willebrand factor levels and distribution of Von Willebrand multimers with the appearance of prosthetic thrombosis at baseline before the procedure, 1-day post-procedure and at 3, 6 months follow-up and 1 year.
- To determine whether the residual platelet reactivity rates in patients undergoing TAVI are associated with the occurrence of clinical events, at baseline before the procedure, 1-day post-procedure and at 3,6 months follow-up and 1 year
- To evaluate the clinical factors associated with the appearance of early prosthetic thrombosis.
- Conditions
- Aortic Stenosis
- Being tested
- CT SCAN
- 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.
CT SCANDiagnostic test
CT SCAN FOR DIAGNOSIS OF HALT
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
platelet reactivity will be measured with the commercial kit platelet Vasodilator Stimulated Phosphoprotein (VASP)/P2Y12 and subclinical valve thrombosis by transthoracic echocardiography and multi-slice computerized tomography
Measured: at 3 months
Secondary outcomes (5)
To measure the variability of platelet aggregation
platelet aggregation
Measured: at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.
To quantify the pro-thrombotic inflammatory response
measured by serum levels of (cluster of differentiation 14) CD14 + and (cluster of differentiation 16) CD16 +
Measured: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis
Serum Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis assessed by transthoracic echocardiography or multi-slice computerized tomography
Measured: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To correlate residual platelet reactivity with clinical events
platelet aggregation
Measured: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To evaluate clinical factors associated with the appearance of early prosthetic thrombosis.
to perform Multislice computerized tomography and clinical follow-up
Measured: multi slice computerized tomography at 3 month and clinical up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jun 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- 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
- 166 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Pilar Jimenez Quevedo, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847948
- Sponsor's protocol ID
- PI17/01685
- Acronym
- START
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No