Brief Title
Biological Factors Associated With Subclinical Valvular Thrombosis
Official Title
Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial
Brief 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 and / or subclinical
prosthetic valve thrombosis measured by echocardiography and multi-slice computerized
tomography
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.
Study Type
Observational [Patient Registry]
Primary Outcome
The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
Secondary Outcome
To measure the variability of platelet aggregation
Condition
Aortic Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
166
Start Date
June 1, 2018
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03847948
Organization ID
PI17/01685
Responsible Party
Principal Investigator
Study Sponsor
Hospital San Carlos, Madrid
Collaborators
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Study Sponsor
, ,
Verification Date
February 2019