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

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ClinicalTrials.gov Identifier: NCT03001960
Recruitment Status : Unknown
Verified December 2016 by Alexander Lauten, Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2016
Last Update Posted : December 28, 2016
Sponsor:
Collaborator:
Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin
Information provided by (Responsible Party):
Alexander Lauten, Charite University, Berlin, Germany

Study Description
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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).


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Intracranial Embolism Drug: Preloading before TAVI Drug: Postloading after TAVI Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)
Study Start Date : March 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Preloading before TAVI
Preloading with Aspirin and Clopidogrel before TAVI
Other Name: ASS, Plavix
Experimental: 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
 Drug: Postloading after TAVI
Postloading with Aspirin and Clopidogrel after TAVI
Other Name: ASS, Plavix


Outcome Measures
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Primary Outcome Measures :
  1. Total volume of new cerebral lesions on MRI after TAVI versus Baseline [ Time Frame: Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline ]

Secondary Outcome Measures :
  1. New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI [ Time Frame: 24-72h post TAVI versus baseline ]
    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).

  2. location of new cerebral lesions early AFTER TAVI [ Time Frame: 24-72h 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

  3. extent of new cerebral lesions early AFTER TAVI [ Time Frame: 24-72h 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

  4. Assessment of different neurocognitive tests before and after TAVI procedure [ Time Frame: 24-72 h after TAVI ]
    To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans

  5. Extent of clinically apparent non-cerebral emboli after TAVI [ Time Frame: 24-72 h after TAVI ]
    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

  6. localization of clinically apparent non-cerebral emboli after TAVI [ Time Frame: 24-72 h after TAVI ]
    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

  7. Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. [ Time Frame: 24-72 h after TAVI ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications:

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Responsible Party: Alexander Lauten, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03001960    
Other Study ID Numbers: DAPT-TAVI 01
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Intracranial Embolism
Embolism
Aortic Valve Stenosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Thromboembolism
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs