NCT06910163

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Juan Vicenty · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated device study