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IST-3 Collaborators meeting. Barcelona, 27 th May 2010. Outline. Informed consent / GCP Update Effect of ECASS-3 Lancet pooled analysis Remaining uncertainties Recruitment: ‘countdown’ to 30/6/11! Maintain high data quality. Informed Consent.

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ist 3 collaborators meeting
IST-3 Collaborators meeting

Barcelona, 27th May 2010

outline
Outline
  • Informed consent / GCP
  • Update
    • Effect of ECASS-3
    • Lancet pooled analysis
    • Remaining uncertainties
  • Recruitment: ‘countdown’ to 30/6/11!
  • Maintain high data quality
informed consent
Informed Consent
  • Oral and written information given to the patient by the investigator
  • Before participation in trial
  • Enough time and opportunity for questions and reflection
informed consent1
Informed Consent
  • Consent signed and personally dated by patient (or a legally acceptable representative)
  • Consent signed and dated by person who conducted the informed consent process
  • 1 copy given to patient, 1 original kept in patient study files, 1 copy in patient medical records
investigator responsibilities
Investigator Responsibilities

Ensure that the rights, safety and welfare of the patients in the study are protected by ensuring that the study is conducted according to:

  • The Protocol
  • All appropriate regulations
investigator must verify that they

Follow approved protocol and amendments

Obtain written informed consent before each patient is entered into the trial

Perform all trial procedures in accordance with the protocol

Only delegate these functions to authorised personnel

Enrol only eligible subjects

Investigator must verify that they:
age and time to randomisation 2008 vs 2009 impact of ecass 3
Age and time to randomisation 2008 vs. 2009: impact of ECASS-3

ECASS-3

report

No. patients recruited per quarter

Year, quarter

slide10

Pooled analysis of rt-PA trials

Time to treatment and odds of ‘good outcome’ (mRS 0-1)

2004

N=2775

2010

N=3670

Lancet 2004, Lancet 2010

slide11

Time to treatment and odds of death:

Does trade-off vary with time?

Test for interaction p= 0.04

Lancet 2010

slide12

Time andodds of symptomatic brain haemorrhage (PH 2)

Test for interaction p= 0.4

Lancet 2010

authors conclusions
Authors conclusions:
  • ‘We need to understand better the factors that prevent alteplase from being effective in individual patients… clinical variables e.g.:
  • age, stroke severity, and comorbidities,
  • factors pertaining to arterial recanalisation (e.g. clot composition, location, size, and collateral flow)
  • ‘all must have a role in the success of thrombolysis, but are poorly understood’
uncertainties about thrombolysis in acute ischaemic stroke key ist 3 questions
Uncertainties about thrombolysis in acute ischaemic stroke: key ist-3 questions
  • Is the upper age limit of 80 years justified?
  • What key features identify patients most likely to benefit?
    • Severity (e.g. NIHSS)?
    • Stroke syndrome (LACI, TACI, POCI)?
    • Radiological (e.g. Hyperdense artery, WML)
    • Fancy imaging: ‘penumbra’, blocked artery?
  • What is the latest time for net benefit?

* Cochrane systematic review Wardlaw et al. BMJ 2009 339; b4584

ongoing randomised trials iv rt pa vs control
Ongoing randomised trials iv rt-PA vs control

*CT, MR perfusion/angiography optional

ist 3 publicity response
IST-3 publicity response!
  • ‘Opinion piece’ titled ‘Intravenous thrombolysis – where are we now?’ -> International Journal of Stroke.
  • Podcast on IJS article
  • Submit IST-3 CT/ MR perfusion & angiography protocol to IJS + podcast
  • IST-3 newsletter editorial
slide17

Recruitment

Need 868 more to reach target

27th May

n=2232

recruitment target
Recruitment target
  • 13 months recruitment remain: need 67 patients per month to reach target 3100.
  • Strategy =
    • New centres will need to work quickly to become active
    • Existing centres – what can we do help you increase recruitment?
  • Other ideas to increase recruitment?
data quality prize the sheila grant award we aim for
Data quality prize: the Sheila Grant Award! We aim for:
  • 100% clinical follow up
  • No missing scans
  • Queries resolved
  • Winner: Ospedale DiBranca: 100% complete data!

Sheila,

our data officer

summary
Summary
  • Last patient to be recruited 30.06.2011
  • Deadlines
    • new centres to complete approvals to join: 31/08/10
    • new centres must randomise their first patient by 31/12/10
  • Final follow-up 31.12.2011
  • Main results @ ESC May 2012
  • IST-3 is very, very important!
    • the last large scale trial of thrombolysis versus control,
    • the only significant-sized trial in older people
    • The only controlled trial collecting baseline perfusion and angiography data in unselected patients
  • We are moving on to trials in ICH (PATCH, TRANCHE)
ist 3 will add important new data
IST-3 will add important new data:
  • ~2000 outcome events -> will double total RCT weight of evidence
  • Effects:
    • in all time windows up to 6h
    • In ~ 1000 patients aged > 80 years.
    • in severe and mild stroke:
      • ~ 300 with NIHSS > 24 (severe),
      • ~ 600 with NIHSS < 5 (mild)
    • On long-term survival (to 5 years+)
  • Value of perfusion/angio data ~ 200 patients
what is ich gcp
What is ICH GCP?
  • International Conference on Harmonisation Guideline for Good Clinical Practice
  • Harmonized tripartite guideline to provide a unified standard for the EU, Japan and US to facilitate the mutual acceptance of clinical data by regulatory authorities in these regions
  • Guidance developed in consideration of current GCP practices in EU, Japan, US, Australia, Canada, Nordic countries & WHO