NCT04484350

Blood Pressure Management in Stroke Following Endovascular Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2020-10-23
• Primary completion: 2023-02-04
• Completion: 2023-05-04
• First posted: 2020-07-23
• Last updated: 2023-11-07

Locations

1 site across 1 country: Canada