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| Name | Class |
|---|---|
| Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- PREloading BEFORE TAVI | Experimental |
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| Group 2 - POSTLoading AFTER TAVI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preloading before TAVI | Drug | Preloading with Aspirin and Clopidogrel before TAVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25756438 | Background | 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. | |
| 23727214 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D020766 | Intracranial Embolism |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001124 | Argininosuccinate Synthase |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D019731 | Carbon-Nitrogen Ligases |
| D008025 | Ligases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Postloading after TAVI | Drug | Postloading with Aspirin and Clopidogrel after TAVI |
|
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. | 24-72 h after TAVI |
| 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. |
| D014694 |
| Ventricular Outflow Obstruction |
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D013988 |
| Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |