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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Aortic Valve Stenosis trials