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Search / Trial NCT06910163

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

Launched by JUAN VICENTY · Mar 27, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Acute Stroke Ischemic Stroke Lv One Test Diagnosis Large Vessel Occlusion (Lvo) Glial Fibrillary Acidic Protein (Gfap) D Dimer

ClinConnect Summary

The COPILOT trial is studying a new approach to quickly treat patients who may be having an acute stroke caused by a blockage in a major blood vessel. This trial will compare how quickly patients can get the necessary treatment (called thrombectomy) when a special blood test is used to assess their condition, versus the standard methods currently in place. The goal is to see if the new blood test helps doctors make faster decisions and provide treatment more quickly.

To participate in this trial, you need to be between 21 and 85 years old, speak and understand either Spanish or English, and live in Puerto Rico. You should also be experiencing symptoms of a stroke that started within the last 6 hours, or your last known healthy state was within the last 18 hours, confirmed by someone trustworthy. If you are eligible and choose to participate, you can expect to undergo the blood test and receive care based on the trial's protocol. It's important to note that this trial is not yet recruiting participants, so there will be a waiting period before enrollment begins.

Gender

ALL

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

About Juan Vicenty

Juan Vicenty is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and rigorous scientific protocols, Juan Vicenty collaborates with healthcare professionals and research institutions to conduct high-quality clinical trials. The organization prioritizes patient safety and ethical standards while striving to accelerate the development of effective treatments across various therapeutic areas. Through a strong emphasis on transparency and collaboration, Juan Vicenty aims to contribute significantly to the evolution of healthcare solutions.

Locations

Caguas, , Puerto Rico

Patients applied

0 patients applied

Trial Officials

Juan C Vicenty Padilla, MD

Principal Investigator

University of Puerto Rico Medical Sciences Campus

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported