CVA (Cerebrovascular Accident)NCT00226096
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
A study testing Labetalol Hydrochloride, Metoprolol tartrate and Hydralazine Hydrochloride in people with CVA (Cerebrovascular Accident) and Cerebral Hemorrhage, run by The George Institute at 20 sites in 3 countries.
Trial summary
The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident), Cerebral Hemorrhage, Intracranial Hemorrhages
- What is being tested?
- Labetalol Hydrochloride, Metoprolol tartrate and Hydralazine Hydrochloride
- How many people
- 404 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Nov 2005to Sep 2007
- Phase
- Interventional
- 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
- Aged 18 years or above
- Acute stroke due to spontaneous ICH confirmed by clinical history \& CT scan
- At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more minutes apart
- Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
- Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit
Who cannot join
- Known definite contraindication to an intensive BP lowering regimen
- Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
- Definite evidence that the ICH is secondary to a structural abnormality in the brain
- 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
- Known advanced dementia or significant pre-stroke disability
Show all 10Show fewer
- Concomitant medical illness that would interfere with outcome assessments and follow up
- Already booked for surgical evacuation of haematoma
- Previous participation in this trial or current participation in another investigational drug trial
- A high likelihood that the patient will not adhere to the study treatment and follow up regimen
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Australia15 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Concord Hospital
Concord, New South Wales, 2138
Gosford Hospital
Gosford, New South Wales, 2250
St George Hospital
Kogarah, New South Wales, 2217
Royal Melbourne Hospital
Melbourne, Victoria, 3050
St Vincent's Hospital
Melbourne, Victoria, 3065
Box Hill Hospital
Melbourne, Victoria, 3128
Alfred Hospital
Melbourne, Victoria, 3181
Austin Health
Melbourne, Victoria
Monash Medical Centre
Melbourne, Victoria
John Hunter Hospital
Newcastle, New South Wales, 2310
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
St Vincent's Hospital
Sydney, New South Wales, 2010
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Westmead Hospital
Westmead, New South Wales, 2145
China3 sites
Regional Coordinating Centre: Peking University First Hospital
Beijing, 100034
Hospitals in China, c/o The George Institute China
Beijing
Regional Coordinating Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
Shanghai, 200025
New Zealand2 sites
North Shore Hospital
Auckland
Christchurch Hospital
Christchurch
About this study
Official title: A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
Read the detailed description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.
Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.
The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death \& disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.
- Being tested
- Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate
- Keywords
- Clinical Trial, Blood Pressure, CVA (Cerebrovascular Accident)
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol HydrochlorideDrug
Metoprolol tartrateDrug
Hydralazine HydrochlorideDrug
Glycerol TrinitrateDrug
Phentolamine mesylateDrug
NicardipineDrug
UrapidilDrug
EsmololDrug
ClonidineDrug
EnalaprilatDrug
NitroprussideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Measured: 3 months
Secondary outcomes (1)
All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
Measured: 24 and 72 hours, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for CVA (Cerebrovascular Accident)Studies 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
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Craig Anderson, PhD, Principal investigator, The George InstituteBruce Neal, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226096
- Sponsor's protocol ID
- NDA1INTERACT
- Status last verified
- Jun 2008
- First submitted
- 23 Sep 2005
- Last updated
- 26 Jun 2008
- Results posted
- No
- 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 18396107Ren 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 40541207Maegele M. Towards optimization in the use of hemostatic agents and blood products in the early treatment of patients with traumatic brain injury (TBI). Curr Opin Anaesthesiol. 2025 Apr 1;38(2):129-135. doi: 10.1097/ACO.0000000000001465. Epub 2025 Feb 14.
PubMed 39945652You 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 38018833Sandset 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 33598552Wang 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 32640944Wang 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 30890109Delcourt C, Zheng D, Chen X, Hackett M, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Woodward M, Huang Y, Robinson T, Lavados PM, Lindley RI, Stapf C, Davies L, Chalmers J, Anderson CS, Sato S; INTERACT Investigators. Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):70-75. doi: 10.1136/jnnp-2016-314414. Epub 2016 Oct 21.
PubMed 27919055Song L, Sandset EC, Arima H, Heeley E, Delcourt C, Chen G, Yang J, Wu G, Wang X, Lavados PM, Huang Y, Stapf C, Wang J, Robinson TG, Chalmers J, Lindley RI, Anderson CS; INTERACT2 Investigators. Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1330-1335. doi: 10.1136/jnnp-2016-313246. Epub 2016 May 13.
PubMed 27178897Qiu M, Sato S, Zheng D, Wang X, Carcel C, Hirakawa Y, Sandset EC, Delcourt C, Arima H, Wang J, Chalmers J, Anderson CS; INTERACT Investigators*. Admission Heart Rate Predicts Poor Outcomes in Acute Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies. Stroke. 2016 Jun;47(6):1479-85. doi: 10.1161/STROKEAHA.115.012382. Epub 2016 May 10.
PubMed 27165954Moullaali TJ, Sato S, Wang X, Rabinstein AA, Arima H, Carcel C, Chen G, Robinson T, Heeley E, Chan E, Delcourt C, Stapf C, Cordonnier C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of delayed intraventricular haemorrhage in the INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):19-24. doi: 10.1136/jnnp-2015-311562. Epub 2016 Jan 8.
PubMed 26746184Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS. Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies. Cerebrovasc Dis. 2015;39(3-4):242-8. doi: 10.1159/000381107. Epub 2015 Mar 25.
PubMed 25823544
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT00226096
- Acronym / sponsor ID
- NDA1INTERACT
- Keywords
- Clinical Trial, Blood Pressure, CVA (Cerebrovascular Accident)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
Detailed description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.
Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.
The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death \& disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or above
- Acute stroke due to spontaneous ICH confirmed by clinical history \& CT scan
- At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more minutes apart
- Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
- Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit
Key exclusion criteria (10 listed)
- Known definite contraindication to an intensive BP lowering regimen
- Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
- Definite evidence that the ICH is secondary to a structural abnormality in the brain
- 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 |
|---|---|---|
| Labetalol Hydrochloride | Drug | – |
| Metoprolol tartrate | Drug | – |
| Hydralazine Hydrochloride | Drug | – |
| Glycerol Trinitrate | Drug | – |
| Phentolamine mesylate | Drug | – |
| Nicardipine | Drug | – |
| Urapidil | Drug | – |
| Esmolol | Drug | – |
| Clonidine | Drug | – |
| Enalaprilat | Drug | – |
| Nitroprusside | Drug | – |
Primary outcome
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Time frame: 3 months
1 secondary outcome
All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
Time frame: 24 and 72 hours, 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
- Results publication: 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.
- 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 39945652Maegele M. Towards optimization in the use of hemostatic agents and blood products in the early treatment of patients with traumatic brain injury (TBI). Curr Opin Anaesthesiol. 2025 Apr 1;38(2):129-135. doi: 10.1097/ACO.0000000000001465. Epub 2025 Feb 14.
- 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 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 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 31085948Wang 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.
- Derived from this study: PubMed 30890109Chen 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.
- Derived from this study: PubMed 27919055Delcourt C, Zheng D, Chen X, Hackett M, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Woodward M, Huang Y, Robinson T, Lavados PM, Lindley RI, Stapf C, Davies L, Chalmers J, Anderson CS, Sato S; INTERACT Investigators. Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):70-75. doi: 10.1136/jnnp-2016-314414. Epub 2016 Oct 21.
- Derived from this study: PubMed 27178897Song L, Sandset EC, Arima H, Heeley E, Delcourt C, Chen G, Yang J, Wu G, Wang X, Lavados PM, Huang Y, Stapf C, Wang J, Robinson TG, Chalmers J, Lindley RI, Anderson CS; INTERACT2 Investigators. Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1330-1335. doi: 10.1136/jnnp-2016-313246. Epub 2016 May 13.
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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
Bruce Neal, PhD principal investigator
The George Institute
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol Hydrochloride, Metoprolol tartrate and Hydralazine Hydrochloride in people with CVA (Cerebrovascular Accident) and Cerebral Hemorrhage, run by The George Institute at 20 sites in 3 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 5 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 26 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, China, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (time frame: 3 months). 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 NCT00226096, which also lists 22 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 26 Jun 2008.