UnknownPhase 3

Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

200 participantsStarted 2017-03

Plain-language summary

TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen. The study evaluates the effect of dual antiplatelet pretreatment on periinterventional embolic cerebral lesions and bleeding complications in patients undergoing transfemoral aortic valve implantation (TF-TAVI).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Patients \>18 years and \<90 years * Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation) * Informed consent Exclusion criteria: * TIA/Stroke within last 90 days * Aortic valve-in-valve procedures * TAVI for treatment of isolated aortic regurgitation * known significant carotid stenosis (\>70%) * Prior myocardial infarction or revascularization with PCI or CABG within past 3 months * Clopidogrel and/ or Aspirin within past 7 days * any other indication for (dual) antiplatelet therapy * Contraindication to MRI (MRI conditional pacemakers accepted!) * participation in another interventional trial * cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure \< 90 mmHg) or need for pre-hospital intubation * cardiac arrest \<90 days prior to randomization * Pregnant or lactating females

What they're measuring

Total volume of new cerebral lesions on MRI after TAVI versus Baseline

Timeframe: Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline

Trial details

NCT IDNCT03001960

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03