NCT03847948Unknown不适用
Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
时间窗: 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
次要结局
- 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.)
研究者
Pilar Jimenez Quevedo
MD, PhD, Principal Investigator
Hospital San Carlos, Madrid
研究点 (2)
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