Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

NCT ID: NCT03001960

Last Updated: 2016-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2018-04-30

Brief 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).

Detailed 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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Intracranial Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1- PREloading BEFORE TAVI

• 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

Group Type: EXPERIMENTAL

Preloading before TAVI

Intervention Type: DRUG

Preloading with Aspirin and Clopidogrel before TAVI

Group 2 - POSTLoading AFTER TAVI

• 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

Group Type: EXPERIMENTAL

Postloading after TAVI

Intervention Type: DRUG

Postloading with Aspirin and Clopidogrel after TAVI

Interventions

Preloading before TAVI

Preloading with Aspirin and Clopidogrel before TAVI

Intervention Type: DRUG

Postloading after TAVI

Postloading with Aspirin and Clopidogrel after TAVI

Intervention Type: DRUG

Other Intervention Names

ASS, Plavix; ASS, Plavix

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Alexander Lauten

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474.

Reference Type: BACKGROUND

PMID: 25756438 (View on PubMed)

Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.

Reference Type: BACKGROUND

PMID: 23727214 (View on PubMed)

Other Identifiers

DAPT-TAVI 01

Identifier Type: -

Identifier Source: org_study_id