Clinical trial NCT06910163: Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO
Official title: Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO (COPILOT): an Effectiveness Cluster Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Stroke
Keywords: Acute Stroke
Ischemic Stroke
LVOne Test
Diagnosis
Large Vessel Occlusion (LVO)
Glial Fibrillary Acidic Protein (GFAP)
D-dimer
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: Mennonite Health System
First posted: 2025-04-04
Enrollment: 520
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The COPILOT trial, a cluster randomized crossover study within the Sistema de Salud Menonita (SSM) hospital network, evaluates whether early detection of large vessel occlusion (LVO) stroke via a novel blood test accelerates triage-to-thrombectomy time.

Phase 0 (3 months): Baseline data collection to establish pre-intervention comparisons. Patients receive standard care, and an interim analysis assesses recruitment and study power.

Phase 1 (12 months): Clusters are randomized to intervention (LVOne test) or control (standard care). Analysts remain blinded, and interim analysis reassesses recruitment and primary outcomes.

Phase 2 (12 months): Clusters switch roles, enabling within-cluster comparisons. Due to the intervention's nature, participants and staff cannot be blinded.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the time from triage assessment to thrombectomy puncture
timeFrame: 24 hours
Secondary outcomes:
measure: Time from spoke hospital triage assessment to LVOne test in intervention
timeFrame: 24 hours
measure: Time from HUB hospital triage assessment to LVOne test in intervention
timeFrame: 24 hours
measure: Time from HUB hospital triage assessment to thrombectomy puncture
timeFrame: 24 hours
measure: Thrombectomy rate (proportion of treated LVO)
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 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
measure: Length of ICU stay
timeFrame: 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
measure: Diagnostic accuracy for LVO detection
timeFrame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
measure: Diagnostic accuracy for intracerebral hemorrhage detection
timeFrame: At the time of initial assessment and confirmed by diagnostic imaging within 24 hours
measure: Modified Rankin Scale (mRS)
timeFrame: At the time of initial assessment, 24 hours, at discharge, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Caguas
country: Puerto Rico
facility: Hospital Menonita Caguas
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Juan C Vicenty Padilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malhotra K, Gornbein J, Saver JL. Ischemic Strokes Due to Large-Vessel Occlusions Contribute Disproportionately to Stroke-Related Dependence and Death: A Review. Front Neurol. 2017 Nov 30;8:651. doi: 10.3389/fneur.2017.00651. eCollection 2017.
citation: Victor P, Bian E, Mamdouh H, Mohamed GA, Nour HA, Miller K, Singh K, Patel S, Segovis C, Nahab F. Upfront vascular imaging in acute stroke: Impact on thrombectomy transfer time at a primary stroke center. J Stroke Cerebrovasc Dis. 2024 Aug;33(8):107815. doi: 10.1016/j.jstrokecerebrovasdis.2024.107815. Epub 2024 Jun 13.
citation: Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.
citation: Durrani Y, Gerstl JVE, Murphy D, et al. Prospective Validation of Glial Fibrillary Acidic Protein, d -Dimer, and Clinical Scales for Acute Large-Vessel Occlusion Ischemic Stroke Detection . Stroke: Vascular and Interventional Neurology. Published online May 17, 2024. doi:10.1161/svin.123.001304
citation: Gaude E, Nogueira B, Ladreda Mochales M, Graham S, Smith S, Shaw L, Graziadio S, Ladreda Mochales G, Sloan P, Bernstock JD, Shekhar S, Gropen TI, Price CI. A Novel Combination of Blood Biomarkers and Clinical Stroke Scales Facilitates Detection of Large Vessel Occlusion Ischemic Strokes. Diagnostics (Basel). 2021 Jun 22;11(7):1137. doi: 10.3390/diagnostics11071137.
citation: Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.
citation: Puetz V, Dzialowski I, Hill MD, Subramaniam S, Sylaja PN, Krol A, O'Reilly C, Hudon ME, Hu WY, Coutts SB, Barber PA, Watson T, Roy J, Demchuk AM; Calgary CTA Study Group. Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke. 2008 Nov;3(4):230-6. doi: 10.1111/j.1747-4949.2008.00221.x.
citation: Bamford J. Clinical examination in diagnosis and subclassification of stroke. Lancet. 1992 Feb 15;339(8790):400-2. doi: 10.1016/0140-6736(92)90085-h. No abstract available.
citation: van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
citation: Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.
citation: Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available.
citation: Menon BK, Smith EE, Modi J, Patel SK, Bhatia R, Watson TW, Hill MD, Demchuk AM, Goyal M. Regional leptomeningeal score on CT angiography predicts clinical and imaging outcomes in patients with acute anterior circulation occlusions. AJNR Am J Neuroradiol. 2011 Oct;32(9):1640-5. doi: 10.3174/ajnr.A2564. Epub 2011 Jul 28.