Blood Pressure Management in Stroke Following Endovascular Treatment

NCT04484350 | Completed Phase 2

• 1 other identifier: DETECT-v1.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

endovascular stroke treatment; successful recanalization; transcranial Doppler Ultrasound; intracranial hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Number of participants with any intracranial hemorrhage.

  24±12 hours from treatment initiation

• Absolute difference in flow velocity measurements in transcranial Doppler.

  0-18 hours from treatment initiation

• Absolute difference in the NIH Stroke Scale change at day 1.

  24±12 hours from treatment initiation

• Absolute difference in the NIH Stroke Scale change at day 2.

  48±12 hours from treatment initiation

Other Outcomes (12)

• Absolute difference in mean systolic blood pressure values.

  48 hours from treatment initiation

• Number of participants with symptomatic intracranial hemorrhage.

  24±12 hours from treatment initiation

• Number of deaths during hospitalization.

  Day 7 from treatment initiation or hospital discharge

Study Arms (2)

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.

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.

Drug: Labetalol; Drug: Hydralazine; Drug: Enalapril

Interventions

Labetalol DRUG

10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)

Intensive Blood Pressure management; Standard Blood Pressure management

Hydralazine DRUG

10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)

Intensive Blood Pressure management; Standard Blood Pressure management

Enalapril DRUG

1.25 - 2.5 mg IV bolus and then q6h PRN.

Intensive Blood Pressure management; Standard Blood Pressure management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Stroke; Bites and Stings; Intracranial Hemorrhages

Interventions

Labetalol; Hydralazine; Enalapril

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Aristeidis H Katsanos, MD

  Hamilton General Hospital, Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 23, 2020
• Study Start: October 23, 2020
• Primary Completion: February 4, 2023
• Study Completion: May 4, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)