Hamilton General Hospital
Hamilton, Ontario, L8L2X2, Canada
NCT Number: NCT04484350
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Hamilton, Ontario, L8L2X2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
1.25 - 2.5 mg IV bolus and then q6h PRN.
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.
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.
Time frame: 24±12 hours from treatment initiation
As identified in the follow-up computed tomography scan.
Time frame: 0-18 hours from treatment initiation
Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination.
Time frame: 24±12 hours from treatment initiation
NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
Time frame: 48±12 hours from treatment initiation
NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke.
Time frame: 48 hours from treatment initiation
Difference in mean systolic blood pressure values between the two arms.
Time frame: 24±12 hours from treatment initiation
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.
Time frame: Day 7 from treatment initiation or hospital discharge
All-cause in-hospital mortality.
Time frame: Day 90±10 from treatment initiation
All-cause mortality.
Time frame: 24 hours from treatment initiation
Defined as ≥4 points decline in the National Institute of Health Stroke Scale (NIHSS) from randomization or death.
Time frame: Day 7 from treatment initiation or hospital discharge
Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).
Time frame: Day 90±10 from treatment initiation
Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS).
Time frame: Day 7 from treatment initiation or hospital discharge
Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.
Time frame: Day 90±10 from treatment initiation
Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2.
Time frame: 24±12 hours from treatment initiation
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.
Time frame: Day 7 from treatment initiation
As assessed in the magnetic resonance imaging (MRI) scan, when available.
Time frame: Day 7 from treatment initiation or hospital discharge
Duration of hospital length of stay in days.
Hamilton Health Sciences Corporation
Other
Acronym: DETECT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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