Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT)

March 27, 2025 updated by: Juan Vicenty

Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT): an Effectiveness Cluster Randomized Crossover Trial

Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The COPILOT trial utilizes a cluster randomized crossover design within the Sistema de Salud Menonita (SSM) hospital network to evaluate if early detection of large vessel occlusion (LVO) stroke with a novel blood test can accelerate the time from triage assessment to thrombectomy puncture. It will unfold in three phases:

Phase 0 - Baseline Data Collection (3 months): Before the random allocation, all clusters undergo data collection on baseline characteristics and outcome measures to confirm/set a pre-intervention comparison ground. Phase 0 patients will receive the current standard of care. An interim analysis will check recruitment rates and explore the need for additional clusters for adequate study power.

Phase 1 - Intervention and Control (12 months): Clusters are randomized to either the intervention or control group, with the intervention arm implementing the LVOne test and the control arm continuing standard care without the LVOne test. Data analysts remain blinded to group allocation, while an interim analysis revisits recruitment and primary outcomes to assess whether additional clusters are required.

Phase 2 - Crossover (12 months): Clusters switch roles from Phase 1, allowing every cluster to experience both the intervention and control conditions, facilitating within-cluster comparisons. The nature of the intervention prevents the blinding of participants and staff.

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Hospital Menonita Caguas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 21 to 85 years old
  • Language: Speak and understand Spanish or English
  • Residence: Resident of Puerto Rico
  • Clinical presentation: Suspected acute stroke
  • Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
  • Time of symptom onset: symptoms are known to have begun within the last 6 hours, OR last known to be well between 6 and 18 hours ago, confirmed by a reliable witness or healthcare professional

Exclusion Criteria:

  • Previous healthcare encounter:
  • Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
  • Received thrombolysis therapy before consent (e.g., tPA, alteplase)
  • Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
  • Modified Rankin Scale: Pre-stroke mRS ≥ 3
  • The patient is a pregnant woman
  • The patient is under legal custody or deprived of liberty in penitentiary institutions
  • The patient is unable to provide informed consent on their own and whose authorized legal representatives are unavailable in person or by telephone during recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Participants will receive the current diagnostic standard of care.
Diagnostic test: Diagnostic standard of care
Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.
Experimental: LVOne Test
Participants will receive the LVOne test alongside the current standard of care.
Diagnostic test: Diagnostic standard of care
Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.
Diagnostic test: LVOne Test
Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the time from triage assessment to thrombectomy puncture
Time Frame: 24 hours
The difference in time from the participant triage assessment to thrombectomy puncture.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from spoke hospital triage assessment to LVOne test in intervention
Time Frame: 24 hours
Difference in time from triage assessment to the performance of the LVOne test in the intervention group.
24 hours
Time from HUB hospital triage assessment to LVOne test in intervention
Time Frame: 24 hours
The difference in time from the HUB hospital triage assessment to the performance of the LVOne test.
24 hours
Time from HUB hospital triage assessment to thrombectomy puncture
Time Frame: 24 hours
The difference in time from the HUB hospital triage assessment to the thrombectomy puncture.
24 hours
Thrombectomy rate (proportion of treated LVO)
Time Frame: 24 hours
The number of participants that received thrombectomy.
24 hours
Length of hospital stay
Time Frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
The participant's hospitalization period.
From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Length of ICU stay
Time Frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
The participant's hospitalization period in the intensive care unit (ICU).
From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days
Diagnostic accuracy for LVO detection
Time Frame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
The ability of the test to correctly identify large vessel occlusion (LVO) in patients with suspected acute ischemic stroke. Diagnostic accuracy will be assessed by comparing the test results to the reference imaging standards.
At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Diagnostic accuracy for intracerebral hemorrhage detection
Time Frame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
The ability of the LVOne test to correctly detect intracerebral hemorrhage (ICH) in patients presenting with acute stroke symptoms. Diagnostic accuracy will be determined by comparing LVOne test results to diagnostic imaging.
At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
Modified Rankin Scale (mRS)
Time Frame: At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months
The modified Rankin Scale (mRS) is a measure of functional outcome assessing the degree of disability or dependence in daily activities. The scale ranges from 0 (no symptoms) to 6 (death).
At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Vicenty

Collaborators

University of Puerto Rico
Mennonite Health System

Investigators

  • Principal Investigator: Juan C Vicenty Padilla, MD, University of Puerto Rico Medical Sciences Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2410303013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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