Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin
• Treatments: Aspirin; Clopidogrel

Criteria

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