Acute Ischemic StrokeNCT04775147
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)
A study testing Intensive BP lowering in people with Acute Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intensive BP lowering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2020to 3 Jan 2023
- 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
- Age ≥18 years
- Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
- To receive MT <24 hours after AIS onset according to local guidelines
- Successful recanalization (TICI score ≥2b) after MT
- Sustained systolic BP ≥140 mmHg (defined as 2 successive readings <10 mins) within 60 minutes after recanalization
- Provide written informed consent (or approved surrogate)
- Perform CTA or MRI before endovascular therapy
- Signed an approved informed consents
Who cannot join
- Significant pre-stroke disability (mRS scores 2-5)
- Definite indication/contraindication to different intensities of BP lowering treatment
- Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
- Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
- Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
- Other conditions inappropriate for inclusion judged by investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
About this study
Official title: Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.
Read the detailed description
CRISIS I aims to determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to standard BP management target (<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intensive BP lowering
- Keywords
- Mechanical thrombectomy, Blood pressure management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP loweringOther
The aim is to achieve a systolic BP level of <120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Achieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. Receives: Other: Intensive BP lowering |
| Control group | No intervention | Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of disability
a shift (improvement) in scores (0-6) on the modified Rankin scale
Measured: 90 days (3months)
Secondary outcomes (3)
Intracerebral hemorrhage
Any or symptomatic ICH (sICH) after endovascular therapy
Measured: 90 day
Death or neurological severity
Death or dependency measured by National Institutes of Health stroke scale (NIHSS)
Measured: 7 days
BP lowering target (<120 mmHg)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start3 Jul 2020
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: Results of ENCHANTED have been published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775147
- Sponsor's protocol ID
- CRISIS I
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang L, Deng X, Li C, Zhou Y, Huang H, Xu Q, Cao Z, Nie Z, Cheng X, Shi Y, Peng M, Deng Q, Fang X, Pan C, Ye J, Jiang Z, Guo C, Mantini D, Ding Z, Lu G, Shi F, Yin X, Wang S, Zhu W, Zhang Z; Multi-Center Cooperative Clinical Study Group for "Lesion-Phenotype Brain Mapping in Acute Stroke". Refined AI-ASPECTS with modified atlas and lesion-load thresholds: advancing acute ischemic stroke imaging and prognostic prediction. BMC Med. 2026 Jul 3. doi: 10.1186/s12916-026-05013-5. Online ahead of print.
PubMed 42399913
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
- ClinicalTrials.gov ID
- NCT04775147
- Acronym / sponsor ID
- CRISIS I
- Conditions
- Acute Ischemic Stroke
- Keywords
- Mechanical thrombectomy, Blood pressure management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of ENCHANTED have been published.
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 1 Mar 2021 (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.
CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.
Detailed description
CRISIS I aims to determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to standard BP management target (<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intensive BP loweringAchieving SBP level of <120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. |
| Control group | No intervention | –Maintaining SBP level of <140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
- To receive MT <24 hours after AIS onset according to local guidelines
- Successful recanalization (TICI score ≥2b) after MT
- Sustained systolic BP ≥140 mmHg (defined as 2 successive readings <10 mins) within 60 minutes after recanalization
Key exclusion criteria (6 listed)
- Significant pre-stroke disability (mRS scores 2-5)
- Definite indication/contraindication to different intensities of BP lowering treatment
- Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
- Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
- Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
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 |
|---|---|---|
| Intensive BP loweringThe aim is to achieve a systolic BP level of <120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier) | Other | Intervention group |
Primary outcome
Level of disability
Time frame: 90 days (3months)
a shift (improvement) in scores (0-6) on the modified Rankin scale
3 secondary outcomes
Intracerebral hemorrhage
Time frame: 90 day
Death or neurological severity
Time frame: 7 days
BP lowering target (<120 mmHg)
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Results of ENCHANTED have been published.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 42399913Jiang L, Deng X, Li C, Zhou Y, Huang H, Xu Q, Cao Z, Nie Z, Cheng X, Shi Y, Peng M, Deng Q, Fang X, Pan C, Ye J, Jiang Z, Guo C, Mantini D, Ding Z, Lu G, Shi F, Yin X, Wang S, Zhu W, Zhang Z; Multi-Center Cooperative Clinical Study Group for "Lesion-Phenotype Brain Mapping in Acute Stroke". Refined AI-ASPECTS with modified atlas and lesion-load thresholds: advancing acute ischemic stroke imaging and prognostic prediction. BMC Med. 2026 Jul 3. doi: 10.1186/s12916-026-05013-5. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive BP lowering in people with Acute Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 was stopped early (reason given: Results of ENCHANTED have been published.). Results are not available in the source record.
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?
Level of disability (time frame: 90 days (3months)). 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 NCT04775147, which also lists 1 linked publication.
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 24 Jul 2023.