Status:
COMPLETED
Platelet Reactivity After TAVI: A Multicenter Pilot Study
Lead Sponsor:
Hospital de Meixoeiro
Conditions:
Severe Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use ...
Eligibility Criteria
Inclusion
- For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures.
- Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
- Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
- Patients who are not participating in any other clinical trial or research study (registries allowed).
Exclusion
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Recent stroke \<14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (\>70% stenosis) or life expectancy \< 12 months
- Patients under chronic oral anticoagulation
- Patients with proven allergy to aspirin, clopidogrel or ticagrelor
- Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
- Known pregnancy or breast-feeding
- Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice.
- Thrombocytopenia (\<50,000 platelets U/L) well documented and clinically relevant.
- Patients with documented moderate or severe hepatic insufficiency
- Any condition that may put the patient at risk or influence the outcome of the trial
- Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
- Patients who cannot attend follow up visits scheduled in the study
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02224066
Start Date
January 1 2016
End Date
August 1 2018
Last Update
August 3 2018
Active Locations (7)
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1
Hospital Clinic Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
3
Hospital Santa Creu i Sant Creu
Barcelona, Spain, 08026
4
Hospital Virgen de las Nieves
Granada, Spain, 18014