Evaluate the efficacy of dual antiplatelet therapy versus oral anticoagulation for primary prevention of cerebral thromboembolism at three months after percutaneous aortic valve implantation (TAVI).
Conditions
Interventions
Trade Name: DUOPLAVIN
Pharmaceutical Form: Tablet
INN or Proposed INN: clopidogrel
CAS Number: 113665-84-2
Other descriptive name: clopidogrel (as hydrogen sulphate)
Concentration unit: mg milligram(s
Sponsors
Andres Iñiguez Romo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 .- Adult patients (? 18 years) with ability to understand and accept the participation in the clinical trial. 2 .- Patients with symptomatic degenerative severe aortic stenosis confirmed by imaging studies or invasive method, evaluated by the team of Cardiothoracic Surgery and rejected conventional surgical aortic valve replacement due to unacceptably high risk and accepted for TAVI procedure; 3 .- That they have signed informed consent. 4 .- Patients who are not participating in any clinical trial or research study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1 .- Patients who previously regime are under oral anticoagulation or antiplatelet therapy and post-procedure TAVI have to maintain dual antiplatelet therapy or anticoagulation 2 .- Patients who can not undergo an MRI study for various reasons; 3 .- recent stroke <14 days prior, revascularized coronary artery disease or life expectancy <12 months; 4 .- Patients with proven allergy to aspirin, clopidogrel or acenocoumarol; 5 .- Patients after TAVI procedure can not undergo a regimen of dual antiplatelet therapy or oral anticoagulation for 3 months for any new post-TAVI medical indication; 6 .- Patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the incidence of major vascular events ischemic or hemorrhagic, fatal or nonfatal (cerebral or systemic), the third month after initiation of treatment in both arms after percutaneous aortic valve implantation.;Secondary Objective: ? To assess the frequency of new areas of cerebral infarction among the different treatment regimens after percutaneous aortic valve implantation using magnetic resonance imaging. ? To determine the incidence of major vascular events ischemic or hemorrhagic, fatal or nonfatal (cerebral or systemic), the first and sixth month. ? Evaluate changes in the levels of serum markers of cerebral ischemic damage and correlate them with new areas of cerebral infarction by magnetic resonance imaging after percutaneous aortic valve implantation in both treatment arms. ? Detect the presence of cognitive impairment in stroke patients with aortic valve after percutaneous implant and determine their prognostic implications in both treatment arms.;Primary end point(s): Incidence of major vascular events ischemic or hemorragic, fatal or nonfatal (cerebral or systemic).;Timepoint(s) of evaluation of this end point: 3 months after TAVI implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Frequency of new areas of cerebral infarction among the different treatment regimens after percutaneous aortic valve implantation using magnetic resonance imaging. ? Incidence of major vascular events ischemic or hemorrhagic, fatal or nonfatal (cerebral or systemic), the first and sixth month. ? Levels of serum markers of cerebral ischemic damage and correlate them with new areas of cerebral infarction by magnetic resonance imaging after percutaneous aortic valve implantation in both treatment arms. ? Cognitive impairment in stroke patients after implantation and percutaneous aortic valve ? Quality of life of patients in both treatment arms.;Timepoint(s) of evaluation of this end point: ? Frequency of new areas of cerebral infarction using magnetic resonance imaging:day 10, day 90. ? Incidence of major vascular events ischemic or hemorrhagic, fatal or nonfatal (cerebral or systemic): 30 and 180 day. ? Levels of serum markers of cerebral ischemic damage: day 10. ? Cognitive impairment in stroke: day 90. ? Quality of life of patients: day 90. | — |
Countries
Spain
Contacts
Public Contactcardiovascular clinical trials
Fundación Biomédica del complejo hospitalario de Vigo
Outcome results
None listed