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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Caguas, , Puerto Rico
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