Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

Aortic Valve Stenosis Clinical Trial

— DAPT-TAVI  

Official title:

Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03001960
• Other study ID #: DAPT-TAVI 01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 18, 2016
• Last updated: December 27, 2016
• Start date: March 2017
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Embolism
• Intracranial Embolism
• Transcatheter Aortic Valve Replacement

Intervention

Drug:
• Preloading before TAVI
Preloading with Aspirin and Clopidogrel before TAVI
• Postloading after TAVI
Postloading with Aspirin and Clopidogrel after TAVI

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	PD Dr. David Leistner, Charite University, Department of Cardiology, Berlin, Germany, Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin, Prof. Dr. Ulf Landmesser, Charite University, Department of Cardiology, Berlin, Germany

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of new cerebral lesions on MRI after TAVI versus Baseline		Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline	Yes
Secondary	New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI	Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images).	24-72h post TAVI versus baseline	Yes
Secondary	location of new cerebral lesions early AFTER TAVI	To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan	24-72h after TAVI	No
Secondary	extent of new cerebral lesions early AFTER TAVI	To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan	24-72h after TAVI	No
Secondary	Assessment of different neurocognitive tests before and after TAVI procedure	To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans	24-72 h after TAVI	No
Secondary	Extent of clinically apparent non-cerebral emboli after TAVI	To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)	24-72 h after TAVI	No
Secondary	localization of clinically apparent non-cerebral emboli after TAVI	To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)	24-72 h after TAVI	No
Secondary	Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.		24-72 h after TAVI	No