Clinical trial NCT03847948: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
name: Instituto de Salud Carlos III
First posted: 2019-02-20
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe symptomatic aortic stenosis treated with TAVI

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.

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

Primary outcomes:
measure: The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
timeFrame: at 3 months
Secondary outcomes:
measure: To measure the variability of platelet aggregation
timeFrame: at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.
measure: To quantify the pro-thrombotic inflammatory response
timeFrame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
measure: To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis
timeFrame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
measure: To correlate residual platelet reactivity with clinical events
timeFrame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
measure: To evaluate clinical factors associated with the appearance of early prosthetic thrombosis.
timeFrame: multi slice computerized tomography at 3 month and clinical up to 1 year.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References: