INTERACT2 Protocol Presentation

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A collaboration led by
INTERACT2:
Protocol
INTERACT2: New design features
 Reduced number of in-hospital assessments but
includes and assessment of ICU stay and use of
renal dialysis
 Repeat 24 hr CT scan to be collected only in 600
patients (300 Chinese and 300 non-Chinese)
 Option of telephone-based outcome assessments at
28 and 90 days
 Screening logs kept for only 1 month of the year
 sites to be notified of the randomly selected
month in advance.
 Use of an Interactive Voice Randomisation System
(IVRS) in China
INTERACT2 BP Management
 Evaluation of a management policy and
NOT of a single agent
 Inclusion of BP lowering management
protocols for key available agents
 Pragmatic approach to treatment
 Agents readily available in hospitals
 Agents approved for clinical use
 Lower study costs
Study Outline
Acute spontaneous ICH
onset <6 hours
SBP ≥150 and ≤220 mmHg
No definite indications or contraindications to treatment
Able to be actively managed
Provide informed consent
R
Standard
best
practice
stroke
unit care
Intensive BP lowering
Conservative BP management
Target systolic BP 140 mmHg
within 1 hour and for 24+ hrs
AHA Guideline-based
(treatment if systolic BP >180 mmHg)
Repeat CT scans 24 hrs in selected patients
Vital signs and BP over 7 days
28 day and 3 month follow-up
Sample Size
 2800 patients from 140+ sites
  90% power for:
 14% RRR in death/dependency in active vs
control
 20% RRR in (50%) randomised <4 hours
Network
UK
27 centres
Europe
Austria, Finland, France,
Germany, Portugal, Spain,
Switzerland, The Netherlands,
Italy, Poland
USA
(Rochester)
1 centre
Chile
6 centres
China
49 centres
64 centres
Brazil
9 centres
Argentina
6 centres
India
/Pakistan
13 centres
Australia
14 centres
Inclusion Criteria
 Age 18 years or above
 Acute spontaneous ICH (history and CT)
 At least two systolic BP 150-220 mmHg,
recorded ≥2 min apart
 Able to be randomly assigned BP lowering
therapy within 6 hours of stroke onset
 Able to receive active (‘intensive’) care in a
monitored facility
Exclusion Criteria
 Known definite contraindication to intensive
BP lowering
 Known definite indication to intensive BP
lowering
 ICH secondary to a structural abnormality
 Ischemic stroke in last 30 days
 High likelihood of death within 24 hours
(GCS 3-5)
Exclusion Criteria (cont.)
 Known advanced dementia or significant
pre-stroke disability
 Concomitant medical illness
 Planned early surgical intervention
 Participation in other trial
 Unlikely to adhere to treatment or follow-up
Eligibility
To be eligible for INTERACT2:
 All inclusion criteria questions must be
answered “YES”
 All exclusion criteria questions must be
answered as “NO”
Randomisation system
Randomised to
either
Intensive BP
lowering
treatment
Control; current
guideline based
management of
BP
Patients are stratified according to: time since stroke onset
(0-4 vs. 4-6 hours), site and country of recruitment
Schedule of Assessments
Evaluation
Prior to
Randomisation
Eligibility
X
CT scan
X
Fevers to be recorded
X
BP/Heart rate
X
BP x 2
Consent (a)
X
Clinical history prior medications
X
Physical exam GCS/NIHSS
X
Day
1
7(b)
X
X
X
X
Only first 600
patients
X
X
15min during 1st hr
hourly for 2-6hr
6 hourly for 6-24hr
X
X
X
HRQoL assessment with EQ 5D
X
90(c)
X
Functional assessment with mRS
Standard care & routine blood tests
28(c)
X
BP lowering treatment
X
X
X
X
Standard stroke care
X
X
X
X
Hospitalised or not
X
X
X
X
Contact details for Follow-Up
X
X
Outcomes
 Primary – composite of death or dependency (ie score 3–5 on the
modified Rankin Scale [mRS]) at 90 days
 Secondary:
 Key – primary endpoint in patients <4 hrs of ICH onset
 Others
 Death
 Dependency;
 Disability on the mRS
 HRQoL (using the EuroQoL and health utility score EQ5D)
 Recurrent stroke after 24 hrs of initial ICH
 Other major CV events (myocardial infarction or sudden death)
 Need for permanent residential care
 Duration of initial hospitalisation.
Summary
 INTERACT2 has been designed to provide
a definitive answer to the management of
elevated BP in patients with acute ICH
 If successful, thousands of patients could
benefit, with associated major health gains
Acknowledgements




Patients and families
Participating hospitals and staff
Many project staff in multiple countries
Funding:
 National Health and Medical Research
Council of Australia
 The George Institute for Global Health
Acknowledgements
Executive committee: Craig Anderson (Principal Investigator), John Chalmers (Chair),
Hisatomi Arima, Stephen Davis, Emma Heeley, Yining Huang, Richard Lindley, Bruce Neal,
Mark Parsons, Christian Stapf, Christophe Tzourio and Jiguang Wang.
China steering committee: Yining Huang, Jiguang Wang, Liying Cui, Shengdi Chen,
Zhenguo Liu, Chuanzhen Lu, Qidong Yang, En Xu, Jingfen Zhang, Chaodong Zhang,
Shizheng Wu and Xining Yan Chen
European advisory board: Austria – Ronny Beer, Erich Schmutzhard; Belgium – Patricia
Redondo; Finland – Markku Kaste, Lauri Soinne, Turgut Tatlisumak; France – Christian
Stapf, Christophe Tzourio, Eric Vicaut; Germany – Katja Wartenberg; Italy – Stefano Ricci;
Netherlands – Karin Klijn; Portugal – Jose´ Ferro; Spain – Angel Chamorro; Switzerland –
Marcel Arnold, Urs Fischer; UK – Tom Robinson.
Operations committee: Emma Heeley, Candice Delcourt.
International coordinators: Michelle Leroux, Tara Sasse, Jun Hata, Gouyjen, Tina
Cheung, Cathy Boreham, Sarah Leighton.
Regional coordinators: Americas – Alejandro Rabinstein; Argentina – Conrado J. Estol,
Mariana Zimmermann; Brazil – Gisele Silva, Joyce Marinho; Chile – Pablo Lavados; China –
Jian Sun, Nan Li, Zhao Yan, Chen Xiaoying; France – Sofiane Kabla, Cecile Dert; India –K
Mallickarjuna, Najam Hassan, Jeyaraj Pandian.
DSMB members: John Simes (Chair), Marie-Germaine Bousser, Graeme Hankey, Konrad
Jamrozik (deceased in 2010), Claiborne Johnston and Li Shunwei.
Statisticians: Laurent Billot, Stephane Heritier and Qiang Li.
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