Stroke, AcutePhase 2DETECTNCT04484350
Blood Pressure Management in Stroke Following Endovascular Treatment
A Phase 2 study testing Labetalol, Hydralazine and Enalapril in people with Stroke, Acute and Vessels; Occlusion, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the hypothesis that intensive blood pressure control immediately after successful endovascular stroke thrombectomy can improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Vessels; Occlusion, Blood Pressure
- What is being tested?
- Labetalol, Hydralazine and Enalapril
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2020to 4 May 2023
- Phase
- Phase 2
- 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 equal or more than 18 years.
- Eligible for endovascular treatment (EVT) within 24 hours from symptom onset according to current clinical practice.
- Presence of a proximal large vessel occlusion in the anterior circulation, defined as occlusion of the intracranial segment of the internal carotid artery and/or occlusion of the M1 segment or proximal M2 segment of the middle cerebral artery.
- Successful recanalization after the end of the EVT procedure, defined as modified thrombolysis in cerebral ischemia (mTICI) score equal or more than 2b.
- Sustained elevated systolic BP level after recanalization, defined as 2 consecutive systolic BP readings ≥ 150 mmHg (or ≥ 140 mmHg if the participant has a known history of hypertension) taken more than 5 minutes apart.
- Ability of the patient or legal representative to provide informed consent.
- Randomization within 60 minutes from the end of the EVT procedure.
Who cannot join
- Presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT.
- Symptomatic intracranial hemorrhage after the end of EVT procedure.
- Any medical condition where randomization to either standard or intensive BP lowering would not be acceptable at the discretion of the investigators and/or the treating physician.
- Pregnancy.
- Enrollment in another acute stroke therapeutic trial.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the hypothesis that intensive blood pressure control immediately after successful endovascular stroke thrombectomy can improve patient outcomes. Patients with stroke who have ongoing high blood pressure after successful clot retrieval will be included. Participants will be randomly placed (like flipping a coin) in one of two groups. There will be a 50% chance of each patient being placed to either group. The first group will be allowed to have a higher blood pressure range that is consistent with current recommendations. The second group will be given medications to bring their blood pressure down into a normal range. These blood pressure targets will be maintained for 48 hours. We will collect patient brain images and levels of stroke disability up to 90 days after their clot retrieval.
Read the detailed description
Current guidelines from the American Heart Association/ American Stroke Association (AHA/ ASA) propose thresholds of systolic blood pressure (BP) less than 180 mm Hg and diastolic BP less than 105 mm Hg during and for the first 24 hours following endovascular treatment (EVT), which have been arbitrarily inherited from previous intravenous thrombolysis guidelines. Although there is plethora of evidence from observational cohort studies suggesting that increased BP following EVT is associated with higher likelihood of both intracranial hemorrhage and unfavorable clinical outcomes, the potential for residual confounding in these observational datasets limits their interpretation. The blooD prEssure management in sTroke following EndovasCular Treatment (DETECT) trial is a single-center, pragmatic, pilot, prospective open label, blinded end point, randomized controlled trial testing the hypothesis that intensive BP management following successful EVT is feasible. The primary objective of DETECT is to determine the feasibility of a RCT assessing the efficacy and safety of intensive BP lowering compared to standard of care in rates of hemorrhagic transformation and functional outcome following successful EVT in acute ischemic stroke patients with large vessel occlusion. We will include adult patients with acute ischemic stroke achieving successful reperfusion (TICI more or equal to 2b) of a proximal large vessel occlusion in the anterior circulation after EVT. Eligible patients will be randomized 1:1 within 60 minutes from the end of the EVT procedure to either intensive (systolic BP target <140 mmHg) or standard BP management (systolic BP target <180 mmHg) for the first 48 hours after randomization. Patients with presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT, and/or patients having any medical condition where randomization to either standard or intensive BP lowering would not be acceptable at the discretion of the treating physician will be excluded from participating. The trial will be embedded within an established national EVT registry that focuses on improving quality of management of patients receiving EVT for ischemic stroke.
- Conditions
- Stroke, Acute, Vessels; Occlusion, Blood Pressure, Endovascular Thrombectomy, Mechanical Thrombectomy
- Being tested
- Labetalol, Hydralazine, Enalapril
- Keywords
- endovascular stroke treatment, successful recanalization, transcranial Doppler Ultrasound, intracranial hemorrhage
- Medical subject headings
- Stroke, Bites and Stings, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
HydralazineDrug
10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
EnalaprilDrug
1.25 - 2.5 mg IV bolus and then q6h PRN.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Blood Pressure management | Experimental | Participants assigned to the intensive blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 140 mmHg for the first 48 hours after enrollment into the study. Receives: Drug: Labetalol; Drug: Hydralazine; Drug: Enalapril |
| Standard Blood Pressure management | Active comparator | Participants assigned to the standard blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 180 mmHg for the first 48 hours after enrollment into the study. Receives: Drug: Labetalol; Drug: Hydralazine; Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean enrollment rate.
The predefined target is to achieve a mean enrollment rate of 2 patients per month.
Measured: through study completion, an average of 18 months
Number of participants with treatment allocation change.
The predefined target is that at least 80% of the participants remain within their assigned treatment group, and not changing treatment allocation for any reason.
Measured: 48 hours from treatment initiation
Secondary outcomes (4)
Number of participants with any intracranial hemorrhage.
As identified in the follow-up computed tomography scan.
Measured: 24±12 hours from treatment initiation
Absolute difference in flow velocity measurements in transcranial Doppler.
Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination.
Measured: 0-18 hours from treatment initiation
Absolute difference in the NIH Stroke Scale change at day 1.
NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
Measured: 24±12 hours from treatment initiation
Absolute difference in the NIH Stroke Scale change at day 2.
NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
Measured: 48±12 hours from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start23 Oct 2020
- Primary completion4 Feb 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aristeidis H Katsanos, MD, Principal investigator, Hamilton General Hospital, Hamilton Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484350
- Sponsor's protocol ID
- DETECT-v1.0
- Acronym
- DETECT
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Management in Stroke Following Endovascular Treatment
- ClinicalTrials.gov ID
- NCT04484350
- Acronym / sponsor ID
- DETECT / DETECT-v1.0
- Conditions
- Stroke, Acute, Vessels; Occlusion, Blood Pressure, Endovascular Thrombectomy, Mechanical Thrombectomy
- Keywords
- endovascular stroke treatment, successful recanalization, transcranial Doppler Ultrasound, intracranial hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 23 Jul 2020 (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.
The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the hypothesis that intensive blood pressure control immediately after successful endovascular stroke thrombectomy can improve patient outcomes. Patients with stroke who have ongoing high blood pressure after successful clot retrieval will be included. Participants will be randomly placed (like flipping a coin) in one of two groups. There will be a 50% chance of each patient being placed to either group. The first group will be allowed to have a higher blood pressure range that is consistent with current recommendations. The second group will be given medications to bring their blood pressure down into a normal range. These blood pressure targets will be maintained for 48 hours. We will collect patient brain images and levels of stroke disability up to 90 days after their clot retrieval.
Detailed description
Current guidelines from the American Heart Association/ American Stroke Association (AHA/ ASA) propose thresholds of systolic blood pressure (BP) less than 180 mm Hg and diastolic BP less than 105 mm Hg during and for the first 24 hours following endovascular treatment (EVT), which have been arbitrarily inherited from previous intravenous thrombolysis guidelines. Although there is plethora of evidence from observational cohort studies suggesting that increased BP following EVT is associated with higher likelihood of both intracranial hemorrhage and unfavorable clinical outcomes, the potential for residual confounding in these observational datasets limits their interpretation. The blooD prEssure management in sTroke following EndovasCular Treatment (DETECT) trial is a single-center, pragmatic, pilot, prospective open label, blinded end point, randomized controlled trial testing the hypothesis that intensive BP management following successful EVT is feasible. The primary objective of DETECT is to determine the feasibility of a RCT assessing the efficacy and safety of intensive BP lowering compared to standard of care in rates of hemorrhagic transformation and functional outcome following successful EVT in acute ischemic stroke patients with large vessel occlusion. We will include adult patients with acute ischemic stroke achieving successful reperfusion (TICI more or equal to 2b) of a proximal large vessel occlusion in the anterior circulation after EVT. Eligible patients will be randomized 1:1 within 60 minutes from the end of the EVT procedure to either intensive (systolic BP target <140 mmHg) or standard BP management (systolic BP target <180 mmHg) for the first 48 hours after randomization. Patients with presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT, and/or patients having any medical condition where randomization to either standard or intensive BP lowering would not be acceptable at the discretion of the treating physician will be excluded from participating. The trial will be embedded within an established national EVT registry that focuses on improving quality of management of patients receiving EVT for ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Blood Pressure management | Experimental | Drug: Labetalol, Drug: Hydralazine, Drug: EnalaprilParticipants assigned to the intensive blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 140 mmHg for the first 48 hours after enrollment into the study. |
| Standard Blood Pressure management | Active comparator | Drug: Labetalol, Drug: Hydralazine, Drug: EnalaprilParticipants assigned to the standard blood pressure management arm will be treated using approved antihypertensive medications to have systolic blood pressure readings under 180 mmHg for the first 48 hours after enrollment into the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age equal or more than 18 years.
- Eligible for endovascular treatment (EVT) within 24 hours from symptom onset according to current clinical practice.
- Presence of a proximal large vessel occlusion in the anterior circulation, defined as occlusion of the intracranial segment of the internal carotid artery and/or occlusion of the M1 segment or proximal M2 segment of the middle cerebral artery.
- Successful recanalization after the end of the EVT procedure, defined as modified thrombolysis in cerebral ischemia (mTICI) score equal or more than 2b.
- Sustained elevated systolic BP level after recanalization, defined as 2 consecutive systolic BP readings ≥ 150 mmHg (or ≥ 140 mmHg if the participant has a known history of hypertension) taken more than 5 minutes apart.
Key exclusion criteria (5 listed)
- Presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or remaining stenosis ≥80% after the end of the EVT.
- Symptomatic intracranial hemorrhage after the end of EVT procedure.
- Any medical condition where randomization to either standard or intensive BP lowering would not be acceptable at the discretion of the investigators and/or the treating physician.
- Pregnancy.
- Enrollment in another acute stroke therapeutic trial.
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 |
|---|---|---|
| Labetalol10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours) | Drug | Intensive Blood Pressure management, Standard Blood Pressure management |
| Hydralazine10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours) | Drug | Intensive Blood Pressure management, Standard Blood Pressure management |
| Enalapril1.25 - 2.5 mg IV bolus and then q6h PRN. | Drug | Intensive Blood Pressure management, Standard Blood Pressure management |
Primary outcome
Mean enrollment rate.
Time frame: through study completion, an average of 18 months
The predefined target is to achieve a mean enrollment rate of 2 patients per month.
Number of participants with treatment allocation change.
Time frame: 48 hours from treatment initiation
The predefined target is that at least 80% of the participants remain within their assigned treatment group, and not changing treatment allocation for any reason.
4 secondary outcomes
Number of participants with any intracranial hemorrhage.
Time frame: 24±12 hours from treatment initiation
Absolute difference in flow velocity measurements in transcranial Doppler.
Time frame: 0-18 hours from treatment initiation
Absolute difference in the NIH Stroke Scale change at day 1.
Time frame: 24±12 hours from treatment initiation
Absolute difference in the NIH Stroke Scale change at day 2.
Time frame: 48±12 hours from treatment initiation
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 7 Nov 2023.
- Individual participant dataSharing planned: Yes
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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.
Aristeidis H Katsanos, MD principal investigator
Hamilton General Hospital, Hamilton Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Labetalol, Hydralazine and Enalapril in people with Stroke, Acute and Vessels; Occlusion, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 7 inclusion and 5 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 7 Nov 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean enrollment rate. (time frame: through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.