Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 166
- Locations
- 2
- Primary Endpoint
- The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
- Last Updated
- 4 years ago
Overview
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.
Investigators
Pilar Jimenez Quevedo
MD, PhD, Principal Investigator
Hospital San Carlos, Madrid
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
Outcomes
Primary Outcomes
The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
Time Frame: at 3 months
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
Secondary Outcomes
- To measure the variability of platelet aggregation(at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.)
- To correlate residual platelet reactivity with clinical events(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.(multi slice computerized tomography at 3 month and clinical up to 1 year.)
- To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis(at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.)
- To quantify the pro-thrombotic inflammatory response(at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.)