Acute StrokeBP-TARGETNCT03160677
Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy
A study testing Systolic blood pressure target < 130 mm Hg and Systolic blood pressure target < 185 mm Hg in people with Acute Stroke and Blood Pressure, run by Fondation Ophtalmologique Adolphe de Rothschild at 7 sites in France.
Trial summary
A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- What is being tested?
- Systolic blood pressure target < 130 mm Hg and Systolic blood pressure target < 185 mm Hg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 7 sitesFrance
- Study dates
- 21 Jun 2017to 31 Jan 2020
- 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
- Intracranial Occlusion of internal carotid arteries and/or proximal middle cerebral (segment M1) diagnosis made on initial Imaging.
- Reperfusion after a thrombectomy procedure (defined by a 2b-3 TICI score -Thrombolysis In Cerebral Infarction- score).
Who cannot join
- Per-procedure hemorrhagic complications (prior to reperfusion)
- Systolic blood pressure at baseline <130 mm Hg within one hour of recanalization
- Pre-existing stroke handicap defined by a Rankin score (modified scale, mRS)> 3
- Hemodynamically significant carotid stenosis
- Occlusion of the isolated cervical carotid artery
- Known pregnancy
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- Legal protection
- Non-affiliation to a social security scheme
- Refusal of the patient (or of his / her relatives in case of urgent inclusion)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux
Bordeaux
Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon
Lyon
Centre Hospitalier Régional Universitaire
Nancy
Hopital Lariboisière
Paris, 75010
Fondation Ophtalmologique A de Rothschild
Paris, 75019
Hopital Foch
Suresnes
Hopital de purpan
Toulouse, 31 100
About this study
Official title: Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation
A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.
Read the detailed description
Patients will be followed for 3 months:
- inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
- within 24 hours after reperfusion: blood pressure measurements
- at 24 hours: measurement of blood pressure (T0 + 24 h and evaluation of the NIHSS score.
- Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). For some centers: Cerebral MRI without injection between H24 and H36
- 72 hours after reperfusion: Cerebral scanner in case of hyperdensity on the initial scanner
- 3 months after reperfusion: disability assessment by Rankin score
- Conditions
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Being tested
- Systolic blood pressure target < 130 mm Hg, Systolic blood pressure target < 185 mm Hg
- Keywords
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systolic blood pressure target < 130 mm HgOther
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg
Systolic blood pressure target < 185 mm HgOther
Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Intensive blood pressure management | Experimental | Not described Receives: Other: Systolic blood pressure target < 130 mm Hg |
| Standard blood pressure management | Active comparator | Not described Receives: Other: Systolic blood pressure target < 185 mm Hg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with intracranial hemorrhagic complications
Rate of patients with intracranial hemorrhagic complications (Symptomatic or asymptomatic) on cerebral scan, evaluated with a double centralized blind reading
Measured: Scan performed between 24 and 36 hours after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start21 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mikael MAZIGHI, MD PhD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160677
- Sponsor's protocol ID
- MMI_2016_26
- Acronym
- BP-TARGET
- Status last verified
- Aug 2021
- First submitted
- 18 May 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maier B, Brauner R, Escalard S, Gory B, Lapergue B, Sibon I, Richard S, Labreuche J, Kyheng M, Desilles JP, Blanc R, Piotin M, Halimi JM, Mazighi M; BP-TARGET Trial Investigators. Association of Contrast Enhancement After Reperfusion With Outcomes According to Blood Pressure Lowering in Patients With Acute Ischemic Stroke. Neurology. 2022 Nov 22;99(21):e2385-e2394. doi: 10.1212/WNL.0000000000201173. Epub 2022 Aug 30.
PubMed 36041869Maier B, Gory B, Lapergue B, Sibon I, Richard S, Kyheng M, Labreuche J, Desilles JP, Blanc R, Piotin M, Mazighi M, Halimi JM; BP TARGET Investigators. Effect of Baseline Antihypertensive Treatments on Stroke Severity and Outcomes in the BP TARGET Trial. Stroke. 2022 Jun;53(6):1837-1846. doi: 10.1161/STROKEAHA.121.037548. Epub 2022 Mar 24.
PubMed 35321558Anadani M, Maier B, Escalard S, Labreuche J, de Havenon A, Sabben C, Lapergue B, Gory B, Richard S, Sibon I, Desilles JP, Blanc R, Piotin M, Mazighi M; of behalf the BP-TARGET Study Group*. Magnitude of Blood Pressure Change After Endovascular Therapy and Outcomes: Insight From the BP-TARGET Trial. Stroke. 2022 Mar;53(3):719-727. doi: 10.1161/STROKEAHA.121.036701. Epub 2022 Feb 3.
PubMed 35109685Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hebert S, Maier B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.
PubMed 33647246
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation
- ClinicalTrials.gov ID
- NCT03160677
- Acronym / sponsor ID
- BP-TARGET / MMI_2016_26
- Conditions
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Keywords
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.
Detailed description
Patients will be followed for 3 months:
- inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
- within 24 hours after reperfusion: blood pressure measurements
- at 24 hours: measurement of blood pressure (T0 + 24 h and evaluation of the NIHSS score.
- Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). For some centers: Cerebral MRI without injection between H24 and H36
- 72 hours after reperfusion: Cerebral scanner in case of hyperdensity on the initial scanner
- 3 months after reperfusion: disability assessment by Rankin score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive blood pressure management | Experimental | Other: Systolic blood pressure target < 130 mm Hg |
| Standard blood pressure management | Active comparator | Other: Systolic blood pressure target < 185 mm Hg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intracranial Occlusion of internal carotid arteries and/or proximal middle cerebral (segment M1) diagnosis made on initial Imaging.
- Reperfusion after a thrombectomy procedure (defined by a 2b-3 TICI score -Thrombolysis In Cerebral Infarction- score).
Key exclusion criteria (9 listed)
- Per-procedure hemorrhagic complications (prior to reperfusion)
- Systolic blood pressure at baseline <130 mm Hg within one hour of recanalization
- Pre-existing stroke handicap defined by a Rankin score (modified scale, mRS)> 3
- Hemodynamically significant carotid stenosis
- Occlusion of the isolated cervical carotid artery
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 |
|---|---|---|
| Systolic blood pressure target < 130 mm HgAdaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg | Other | Intensive blood pressure management |
| Systolic blood pressure target < 185 mm HgAdaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg | Other | Standard blood pressure management |
Primary outcome
Rate of patients with intracranial hemorrhagic complications
Time frame: Scan performed between 24 and 36 hours after thrombectomy
Rate of patients with intracranial hemorrhagic complications (Symptomatic or asymptomatic) on cerebral scan, evaluated with a double centralized blind reading
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 3 Aug 2021.
- Derived from this study: PubMed 36041869Maier B, Brauner R, Escalard S, Gory B, Lapergue B, Sibon I, Richard S, Labreuche J, Kyheng M, Desilles JP, Blanc R, Piotin M, Halimi JM, Mazighi M; BP-TARGET Trial Investigators. Association of Contrast Enhancement After Reperfusion With Outcomes According to Blood Pressure Lowering in Patients With Acute Ischemic Stroke. Neurology. 2022 Nov 22;99(21):e2385-e2394. doi: 10.1212/WNL.0000000000201173. Epub 2022 Aug 30.
- Derived from this study: PubMed 35321558Maier B, Gory B, Lapergue B, Sibon I, Richard S, Kyheng M, Labreuche J, Desilles JP, Blanc R, Piotin M, Mazighi M, Halimi JM; BP TARGET Investigators. Effect of Baseline Antihypertensive Treatments on Stroke Severity and Outcomes in the BP TARGET Trial. Stroke. 2022 Jun;53(6):1837-1846. doi: 10.1161/STROKEAHA.121.037548. Epub 2022 Mar 24.
- Derived from this study: PubMed 35109685Anadani M, Maier B, Escalard S, Labreuche J, de Havenon A, Sabben C, Lapergue B, Gory B, Richard S, Sibon I, Desilles JP, Blanc R, Piotin M, Mazighi M; of behalf the BP-TARGET Study Group*. Magnitude of Blood Pressure Change After Endovascular Therapy and Outcomes: Insight From the BP-TARGET Trial. Stroke. 2022 Mar;53(3):719-727. doi: 10.1161/STROKEAHA.121.036701. Epub 2022 Feb 3.
- Derived from this study: PubMed 33647246Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hebert S, Maier B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.
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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.
Mikael MAZIGHI, MD PhD principal investigator
Fondation Ophtalmologique A. de Rothschild
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systolic blood pressure target < 130 mm Hg and Systolic blood pressure target < 185 mm Hg in people with Acute Stroke and Blood Pressure, run by Fondation Ophtalmologique Adolphe de Rothschild at 7 sites in France.
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 2 inclusion and 9 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Rate of patients with intracranial hemorrhagic complications (time frame: Scan performed between 24 and 36 hours after thrombectomy). 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 NCT03160677, which also lists 4 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 3 Aug 2021.