Biological Factors Associated With Subclinical Valvular Thrombosis

Aortic Stenosis Clinical Trial

— START  

Official title:

Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03847948
• Other study ID #: PI17/01685
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2021
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Thrombosis

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS, Instituto Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 3 months
Secondary	To measure the variability of platelet aggregation	platelet aggregation	at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.
Secondary	To quantify the pro-thrombotic inflammatory response	measured by serum levels of (cluster of differentiation 14) CD14 + and (cluster of differentiation 16) CD16 +	at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
Secondary	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	at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
Secondary	To correlate residual platelet reactivity with clinical events	platelet aggregation	at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
Secondary	To evaluate clinical factors associated with the appearance of early prosthetic thrombosis.	to perform Multislice computerized tomography and clinical follow-up	multi slice computerized tomography at 3 month and clinical up to 1 year.