Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI (DAPT-TAVI)

Charité University Medicine Berlin

Status and phase: Unknown; Phase 3

Conditions: Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Intracranial Embolism

Treatments: Drug: Preloading before TAVI; Drug: Postloading after TAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT03001960

DAPT-TAVI 01

Details and patient eligibility

About

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).

Full description

Patients undergoing TAVI bear a high risk of ischaemic stroke, which is an independent predictor of mortality1. Dual antiplatelet therapy (DAPT) is recommended by current guidelines without clear specifications on the time of initiation of treatment due to a lack of data. While some centers initiate DAPT with aspirin and clopidogrel prior to TAVI to reduce the rate of periinterventional embolic events, others start these medications after the procedure.Data on antithrombotic therapy during TAVI are scarce and no randomized evaluation has been performed to demonstrate what the best strategy is during the procedure.

Therefore, the objective of this clinical trial is to assess the efficacy of pre- versus postoperative dual antiplatelet loading with Aspirin and Clopidogrel on volume of periinterventional cerebral ischemic lesions as quantified by diffusion weight MRI (DW-MRI) and neurocognitive function in patients undergoing transfemoral aortic valve replacement. The statistical trial design assumes superiority of preloading with DAPT regarding the primary endpoint.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Group 1- PREloading BEFORE TAVI

Experimental group

Description:

* Aspirin 100 mg loading orally 6-12 hours before TAVI and * Clopidogrel 600mg loading 6-12 before TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day

Treatment:

Drug: Preloading before TAVI

Group 2 - POSTLoading AFTER TAVI

Experimental group

Description:

* Aspirin 100 mg loading orally 6-12 hours after TAVI and * Clopidogrel 600mg loading 6-12 hours after TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day

Treatment:

Drug: Postloading after TAVI