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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

Tracking Information
First Submitted Date  ICMJE December 18, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date December 28, 2016
Study Start Date  ICMJE March 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • 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).
  • 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
  • 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
  • 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
  • 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...)
  • 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...)
  • Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. [ Time Frame: 24-72 h after TAVI ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI
Official Title  ICMJE Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • Transcatheter Aortic Valve Replacement
  • Intracranial Embolism
Intervention  ICMJE
  • Drug: Preloading before TAVI
    Preloading with Aspirin and Clopidogrel before TAVI
    Other Name: ASS, Plavix
  • Drug: Postloading after TAVI
    Postloading with Aspirin and Clopidogrel after TAVI
    Other Name: ASS, Plavix
Study Arms  ICMJE
  • 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
    Intervention: Drug: Preloading before TAVI
  • 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
    Intervention: Drug: Postloading after TAVI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001960
Other Study ID Numbers  ICMJE DAPT-TAVI 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexander Lauten, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP