Intracerebral HemorrhageINTERACT2NCT00716079
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
A study testing Blood pressure management policies in people with Intracerebral Hemorrhage and Stroke, run by The George Institute at 62 sites in 19 countries.
Trial summary
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke, Hypertension
- What is being tested?
- Blood pressure management policies
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,839 participants
- Where
- 62 sitesin 19 countries
- Study dates
- Sep 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
- Elevated systolic blood pressure (>150mmHg and <220mmHg)
- Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
- Able to be 'actively' treated and admitted to a monitored facility
Who cannot join
- Clear indication or contraindication to intensive BP lowering.
- Evidence ICH secondary to a structural abnormality
- Use of thrombolytic agent
- Previous ischaemic stroke within 30 days
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
Show all 10Show fewer
- Significant pre-stroke disability or advanced dementia
- Planned early neurological intervention
- Participation in another clinical trial.
- A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
Trial locations and contacts
62 sites in 19 countries.
62 sites in 19 countries
France15 sites
Hôpital Jean Minjoz
Besançon, 25030
Hopital de la Cavale-Blanche
Brest, 29609
Centre Hospitalier de Calais
Calais, 62107
CHU Bicetre
Le Kremlin-Bicêtre, 94275
Hopital Roger Salengro
Lille, 59037
Centre Hospitalier de Meaux
Meaux, 77104
CHU Nantes - Hopital Laennec
Nantes, 44093
Hopital de Lariboisiere
Paris, 75010
Centre Hospitalier Sainte Anne
Paris, 75014
Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
Paris, 75475
Hôpital de la Salpêtrière
Paris, 75651
Groupe Hospitalier Paris Saint-Joseph
Paris, 75674
Hopital Tenon
Paris, 75970
Hopital Delafontaine
Saint-Denis, 27993
Centre Hospitalier de Versailles
Versailles, 78157
Germany13 sites
Charite Campus Benjamin Franklin (CCBF)
Berlin, 12200
Universitatsklinikum Dresden
Dresden, 01307
Heinrich-Heine-Universitat
Düsseldorf, 40225
Universitat Erlangen-Nurnberg
Erlangen, 91054
Klinikum Frankfurt
Frankfurt, 15236
Universitatsklinikum Frankfurt
Frankfurt, 60528
Martin-Luther-Universität
Halle, 06120
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Barmbek
Hamburg, 22291
Asklepios Klinik Altona
Hamburg, 22763
University of Heidelberg
Heidelberg, 69120
Universitatsklinikum Mannheim
Mannheim, 68167
Universitatsklinikum Ulm, Oberer Eselsberg
Ulm, 89081
Australia12 sites
Royal Brisbane and Women's Hospital Health Service District
Brisbane, Queensland, 4029
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Concord Hospital
Concord, New South Wales, 2138
Gosford Hospital
Gosford, New South Wales, 2250
Western Hospital
Melbourne, Victoria, 3011
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Austin Repatriation General Hospital
Melbourne, Victoria, 3081
Box Hill Hospital
Melbourne, Victoria, 3128
Monash Medical Centre
Melbourne, Victoria, 3168
John Hunter Hospital
Newcastle, New South Wales, 2310
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Austria3 sites
University of Graz
Graz, 8036
Medizinische Universitat Innsbruck
Innsbruck, A-6020
Allgemeines Krankenhaus Linz
Linz, 4020
Spain3 sites
Hospital General Universitario de Albacete
Albacete
Hospital Clinic Barcelona
Barcelona, 08036
Hospital de Girona Dr. Josep Trueta
Girona, 17007
Belgium2 sites
AZ-VUB (University hospital Brussels)
Jette, 1090
CHU Tivoli
La Louvière, 7100
China2 sites
Regional Coordinating Centre China: The George Institute China
Beijing, Beijing Municipality, 100088
Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
Shanghai, 200025
India1 site
Regional Coordinating Centre India: The George Institute India
Hyderabad, Andhra Pradesh, 500 033
United Kingdom1 site
Regional Coordinating Centre United Kingdom
Leicester
About this study
Official title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.
Read the detailed description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH.
The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.
- Conditions
- Intracerebral Hemorrhage, Stroke, Hypertension
- Being tested
- Blood pressure management policies
- Keywords
- Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure management policiesOther
Also called Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate
The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
| Study group | Role | What they receive |
|---|---|---|
| Intensive BP lowering | Other | Management policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital. Receives: Other: Blood pressure management policies |
| Guideline recommended BP lowering | Other | Patients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Receives: Other: Blood pressure management policies |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
Measured: 90 days
Secondary outcomes (1)
Death at 90 Days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,839 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Craig Anderson, The George Institute
- Investigators
- Craig Anderson, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716079
- Sponsor's protocol ID
- NHMRC-571281
- Acronym
- INTERACT2
- Status last verified
- Nov 2013
- First submitted
- 14 Jul 2008
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.
PubMed 18396107Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.
PubMed 20446945Ren X, Chen X, Hu X, Lin Y, Chen C, Wang J, Robinson TG, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Qureshi AI, Song L, Anderson C, Wang X; as the INTERACT and ATACH-II Investigators. Effects of Blood Pressure Lowering by Hematoma Location in Acute Intracerebral Hemorrhage. Neurology. 2026 Nov 10;107(9):e218514. doi: 10.1212/WNL.0000000000218514. Epub 2026 Oct 8.
PubMed 42848972Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19.
PubMed 41855454Wang X, Ren X, Li Q, Ouyang M, Chen C, Delcourt C, Chen X, Wang J, Robinson T, Arima H, Ma L, Hu X, You C, Li G, Jie Y, Lin Y, Billot L, Munoz-Venturelli P, Martins S, Pontes-Neto OM, Liu L, Chalmers J, Carcel C, Song L, Anderson CS; INTERACT Investigators. Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials. Lancet Neurol. 2025 Jul;24(7):571-579. doi: 10.1016/S1474-4422(25)00160-7.
PubMed 40541207You S, Zheng D, Chen X, Wang X, Ouyang M, Han Q, Cao Y, Delcourt C, Song L, Carcel C, Arima H, Liu CF, Lindley RI, Robinson T, Anderson CS, Chalmers J; INTERACT Investigators. Subacute Neurological Improvement Predicts Favorable Functional Recovery After Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2025 Mar;56(3):621-627. doi: 10.1161/STROKEAHA.124.048847. Epub 2025 Feb 3.
PubMed 39895502You S, Zheng D, Yoshimura S, Ouyang M, Han Q, Wang X, Cao Y, Delcourt C, Song L, Arima H, Chen X, Liu CF, Lindley RI, Robinson T, Anderson CS, Chalmers J; INTERACT Investigators. Optimum Baseline Clinical Severity Scale Cut Points for Prognosticating Intracerebral Hemorrhage: INTERACT Studies. Stroke. 2024 Jan;55(1):139-145. doi: 10.1161/STROKEAHA.123.044538. Epub 2023 Nov 29.
PubMed 38018833Malavera A, You S, Zheng D, Delcourt C, Anderson CS; INTERACT2 Investigators. Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study. J Neurol Sci. 2021 Apr 15;423:117364. doi: 10.1016/j.jns.2021.117364. Epub 2021 Feb 26.
PubMed 33647734Sandset EC, Wang X, Carcel C, Sato S, Delcourt C, Arima H, Stapf C, Robinson T, Lavados P, Chalmers J, Woodward M, Anderson CS. Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2. Eur Stroke J. 2020 Dec;5(4):345-350. doi: 10.1177/2396987320957513. Epub 2020 Sep 20.
PubMed 33598552Song L, Wang X, Ouyang M, Sun L, Chen X, Arima H, Sandset EC, Delcourt C, Wang J, Chen G, Robinson T, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2021 Jan;52(2):722-725. doi: 10.1161/STROKEAHA.120.030435. Epub 2021 Jan 11.
PubMed 33423518Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
PubMed 32640944You S, Zheng D, Delcourt C, Sato S, Cao Y, Zhang S, Yang J, Wang X, Lindley RI, Robinson T, Anderson CS, Chalmers J. Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1409-1414. doi: 10.1161/STROKEAHA.118.024403. Epub 2019 Apr 18.
PubMed 31136288Wang X, Sandset EC, Moullaali TJ, Chen G, Song L, Carcel C, Delcourt C, Woodward M, Robinson T, Chalmers J, Arima H, Anderson CS; INTERACT2 Investigators. Determinants of the high admission blood pressure in mild-to-moderate acute intracerebral hemorrhage. J Hypertens. 2019 Jul;37(7):1463-1466. doi: 10.1097/HJH.0000000000002056.
PubMed 31085948Chen R, Wang X, Anderson CS, Robinson T, Lavados PM, Lindley RI, Chalmers J, Delcourt C. Infratentorial Intracerebral Hemorrhage. Stroke. 2019 May;50(5):1257-1259. doi: 10.1161/STROKEAHA.118.023766.
PubMed 30890109Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.
PubMed 30418098
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
- ClinicalTrials.gov ID
- NCT00716079
- Acronym / sponsor ID
- INTERACT2 / NHMRC-571281
- Conditions
- Intracerebral Hemorrhage, Stroke, Hypertension
- Keywords
- Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,839 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 28 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.
Detailed description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH.
The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP lowering | Other | Other: Blood pressure management policiesManagement policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital. |
| Guideline recommended BP lowering | Other | Other: Blood pressure management policiesPatients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
- Elevated systolic blood pressure (>150mmHg and <220mmHg)
- Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
- Able to be 'actively' treated and admitted to a monitored facility
Key exclusion criteria (10 listed)
- Clear indication or contraindication to intensive BP lowering.
- Evidence ICH secondary to a structural abnormality
- Use of thrombolytic agent
- Previous ischaemic stroke within 30 days
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure management policiesAlso: Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol TrinitrateThe trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets. | Other | Guideline recommended BP lowering, Intensive BP lowering |
Primary outcome
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
Time frame: 90 days
1 secondary outcome
Death at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18396107Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.
- Background: PubMed 20446945Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.
- Derived from this study: PubMed 42848972Ren X, Chen X, Hu X, Lin Y, Chen C, Wang J, Robinson TG, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Qureshi AI, Song L, Anderson C, Wang X; as the INTERACT and ATACH-II Investigators. Effects of Blood Pressure Lowering by Hematoma Location in Acute Intracerebral Hemorrhage. Neurology. 2026 Nov 10;107(9):e218514. doi: 10.1212/WNL.0000000000218514. Epub 2026 Oct 8.
- Derived from this study: PubMed 41855454Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19.
- Derived from this study: PubMed 40541207Wang X, Ren X, Li Q, Ouyang M, Chen C, Delcourt C, Chen X, Wang J, Robinson T, Arima H, Ma L, Hu X, You C, Li G, Jie Y, Lin Y, Billot L, Munoz-Venturelli P, Martins S, Pontes-Neto OM, Liu L, Chalmers J, Carcel C, Song L, Anderson CS; INTERACT Investigators. Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials. Lancet Neurol. 2025 Jul;24(7):571-579. doi: 10.1016/S1474-4422(25)00160-7.
- Derived from this study: PubMed 39895502You S, Zheng D, Chen X, Wang X, Ouyang M, Han Q, Cao Y, Delcourt C, Song L, Carcel C, Arima H, Liu CF, Lindley RI, Robinson T, Anderson CS, Chalmers J; INTERACT Investigators. Subacute Neurological Improvement Predicts Favorable Functional Recovery After Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2025 Mar;56(3):621-627. doi: 10.1161/STROKEAHA.124.048847. Epub 2025 Feb 3.
- Derived from this study: PubMed 38018833You S, Zheng D, Yoshimura S, Ouyang M, Han Q, Wang X, Cao Y, Delcourt C, Song L, Arima H, Chen X, Liu CF, Lindley RI, Robinson T, Anderson CS, Chalmers J; INTERACT Investigators. Optimum Baseline Clinical Severity Scale Cut Points for Prognosticating Intracerebral Hemorrhage: INTERACT Studies. Stroke. 2024 Jan;55(1):139-145. doi: 10.1161/STROKEAHA.123.044538. Epub 2023 Nov 29.
- Derived from this study: PubMed 33647734Malavera A, You S, Zheng D, Delcourt C, Anderson CS; INTERACT2 Investigators. Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study. J Neurol Sci. 2021 Apr 15;423:117364. doi: 10.1016/j.jns.2021.117364. Epub 2021 Feb 26.
- Derived from this study: PubMed 33598552Sandset EC, Wang X, Carcel C, Sato S, Delcourt C, Arima H, Stapf C, Robinson T, Lavados P, Chalmers J, Woodward M, Anderson CS. Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2. Eur Stroke J. 2020 Dec;5(4):345-350. doi: 10.1177/2396987320957513. Epub 2020 Sep 20.
- Derived from this study: PubMed 33423518Song L, Wang X, Ouyang M, Sun L, Chen X, Arima H, Sandset EC, Delcourt C, Wang J, Chen G, Robinson T, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2021 Jan;52(2):722-725. doi: 10.1161/STROKEAHA.120.030435. Epub 2021 Jan 11.
- Derived from this study: PubMed 32640944Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
- Derived from this study: PubMed 31136288You S, Zheng D, Delcourt C, Sato S, Cao Y, Zhang S, Yang J, Wang X, Lindley RI, Robinson T, Anderson CS, Chalmers J. Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1409-1414. doi: 10.1161/STROKEAHA.118.024403. Epub 2019 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Anderson, PhD principal investigator
The George Institute
62 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure management policies in people with Intracerebral Hemorrhage and Stroke, run by The George Institute at 62 sites in 19 countries.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in France, Germany, Australia, Austria, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (time frame: 90 days). 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 NCT00716079, which also lists 43 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 13 Dec 2013.