Blood Pressure Management in Stroke Following Endovascular Treatment

Blood Pressure Clinical Trial

— DETECT  

Official title:

Blood Pressure Management in Stroke Following Endovascular Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484350
• Other study ID #: DETECT-v1.0
• Status: Completed
• Phase: Phase 2
• Start date: October 23, 2020
• Est. completion date: May 4, 2023

Study information

• Verified date: November 2023
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 4, 2023
• Est. primary completion date: February 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Endovascular Thrombectomy
• Mechanical Thrombectomy
• Stroke
• Stroke, Acute
• Vessels; Occlusion

Intervention

Drug:
• Labetalol
10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
• Hydralazine
10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
• Enalapril
1.25 - 2.5 mg IV bolus and then q6h PRN.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute difference in mean systolic blood pressure values.	Difference in mean systolic blood pressure values between the two arms.	48 hours from treatment initiation
Other	Number of participants with symptomatic intracranial hemorrhage.	According to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST), National Institute of Neurological Disorders and Stroke (NINDS) and European-Australian Cooperative Acute Stroke Study 2 (ECASS 2) definitions.	24±12 hours from treatment initiation
Other	Number of deaths during hospitalization.	All-cause in-hospital mortality.	Day 7 from treatment initiation or hospital discharge
Other	Number of deaths during follow-up.	All-cause mortality.	Day 90±10 from treatment initiation
Other	Number of participants with neurological deterioration.	Defined as =4 points decline in the National Institute of Health Stroke Scale (NIHSS) from randomization or death.	24 hours from treatment initiation
Other	Functional outcome during hospitalization.	Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).	Day 7 from treatment initiation or hospital discharge
Other	Functional outcome during follow-up.	Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).	Day 90±10 from treatment initiation
Other	Number of participants with favorable functional outcomes during hospitalization.	Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.	Day 7 from treatment initiation or hospital discharge
Other	Number of participants with favorable functional outcomes during follow-up	Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.	Day 90±10 from treatment initiation
Other	Absolute difference in the decline of the Alberta stroke program early CT scores.	The Alberta Stroke Program Early CT Score (ASPECTS) is a 10-point (range 0-10) quantitative topographic imaging scale with higher scores indicating more favorable imaging profiles. Differences will be assessed between the baseline and repeat computed tomography scan.	24±12 hours from treatment initiation
Other	Absolute difference in final infarct volumes.	As assessed in the magnetic resonance imaging (MRI) scan, when available.	Day 7 from treatment initiation
Other	Absolute difference in hospital stay.	Duration of hospital length of stay in days.	Day 7 from treatment initiation or hospital discharge
Primary	Mean enrollment rate.	The predefined target is to achieve a mean enrollment rate of 2 patients per month.	through study completion, an average of 18 months
Primary	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.	48 hours from treatment initiation
Secondary	Number of participants with any intracranial hemorrhage.	As identified in the follow-up computed tomography scan.	24±12 hours from treatment initiation
Secondary	Absolute difference in flow velocity measurements in transcranial Doppler.	Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination.	0-18 hours from treatment initiation
Secondary	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.	24±12 hours from treatment initiation
Secondary	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.	48±12 hours from treatment initiation