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Aortic Valve StenosisPhase 3DAPT-TAVINCT03001960

Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

A Phase 3 study testing Preloading before TAVI and Postloading after TAVI in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Charite University, Berlin, Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Preloading before TAVI and Postloading after TAVI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Mar 2017to Apr 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients >18 years and <90 years
  • Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation)
  • Informed consent

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

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

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).

Read the 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.

Being tested
Preloading before TAVI, Postloading after TAVI
Medical subject headings
Aortic Valve Stenosis, Intracranial Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preloading before TAVIDrug

    Also called ASS, Plavix

    Preloading with Aspirin and Clopidogrel before TAVI

  • Postloading after TAVIDrug

    Also called ASS, Plavix

    Postloading with Aspirin and Clopidogrel after TAVI

Study groups in NCT03001960
Study groupRoleWhat they receive
Group 1- PREloading BEFORE TAVIExperimental* 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
Receives: Drug: Preloading before TAVI
Group 2 - POSTLoading AFTER TAVIExperimental* 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
Receives: Drug: Postloading after TAVI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total volume of new cerebral lesions on MRI after TAVI versus Baseline

    Measured: Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline

Secondary outcomes (7)

  1. 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).

    Measured: 24-72h post TAVI versus baseline

  2. 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

    Measured: 24-72h after TAVI

  3. 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

    Measured: 24-72h after TAVI

  4. 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

    Measured: 24-72 h after TAVI

  5. Extent of clinically apparent non-cerebral emboli after TAVI

    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

    Measured: 24-72 h after TAVI

  6. localization of clinically apparent non-cerebral emboli after TAVI

    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

    Measured: 24-72 h after TAVI

  7. Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.

    Measured: 24-72 h after TAVI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study startMar 2017
  3. Primary completionMar 2018 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001960
Sponsor's protocol ID
DAPT-TAVI 01
Acronym
DAPT-TAVI
Status last verified
Dec 2016
First submitted
18 Dec 2016
Last updated
28 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25756438

  • 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.

    PubMed 23727214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preloading before TAVI and Postloading after TAVI in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Charite University, Berlin, Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03001960, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.

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