Clinical trial

Blood Pressure Management in Stroke Following Endovascular Treatment

Name
DETECT-v1.0
Description
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.
Trial arms
Trial start
2020-10-23
Estimated PCD
2023-02-04
Trial end
2023-05-04
Status
Completed
Phase
Early phase I
Treatment
Labetalol
10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
Arms:
Intensive Blood Pressure management, Standard Blood Pressure management
Hydralazine
10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
Arms:
Intensive Blood Pressure management, Standard Blood Pressure management
Enalapril
1.25 - 2.5 mg IV bolus and then q6h PRN.
Arms:
Intensive Blood Pressure management, Standard Blood Pressure management
Size
30
Primary endpoint
Mean enrollment rate.
through study completion, an average of 18 months
Number of participants with treatment allocation change.
48 hours from treatment initiation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-11-07

1 organization

3 products

6 indications

Product
Labetalol
Indication
stroke
Indication
Acute
Indication
Hypertension
Product
Enalapril