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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03001960
Other study ID # DAPT-TAVI 01
Secondary ID
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


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
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