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NCT06855394 · ClinicalTrials.gov registry record
Genetic Testing of CYP2C19 in Prognostic Evaluation of Long-Term Major Adverse Cardiac and Vascular Events
A clinical trial of Stroke and Heart Diseases, sponsored by University of Florida.
- Active
- Registry status
- 13,000
- Enrollment target
- 2
- Study locations
NCT06855394: Active study of Stroke and Heart Diseases, sponsored by University of Florida.
NCT06855394 is a study of Stroke and Heart Diseases that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 13,000 participants, roughly in line with the 11,988-participant average among 454 other Stroke trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06855394, a study of Stroke and Heart Diseases, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- 13,000 participants
- Enrollment target
- 2
- Study locations
Study Summary
Several studies have shown that the efficacy of clopidogrel for secondary prevention of major adverse cardiovascular events (MACE), including acute coronary syndrome, depends on the polymorphism of the CYP2C19 gene. However, studies with large sample sizes and long-term follow-up are missing. Moreover, the impact of this polymorphism on the risk of major adverse limb events (MALE), particularly in patients with peripheral artery disease of the lower limb, is unexplored. Additionally, the impact of CYP2C19 gene polymorphism on clopidogrel effectiveness in preventing recurrent stroke in diverse populations is unknown since most of the data are from Asian ancestry populations. We hypothesize that patients with CYP2C19 gene loss of function alleles are at high risk of MACE and MALE compared to those without loss of function alleles at long-term follow-up. We propose to assess MACE and MALE in a large cohort of patients with available CYP2C19 genotypes treated at the University of Florida Health to evaluate the impact of CYP2C19 gene polymorphisms on the risk of new or recurrent events at long-term follow-up. Our specific aims are Aim 1) to determine the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MACE (a composite of all-cause death, non-fatal MI, and non-fatal stroke) at long-term follow-up; Aim 2) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MALE (a composite of limb amputations, chronic threatening limb ischemia, acute limb ischemia, and limb revascularization) at long-term follow-up; and Aim 3) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of cerebrovascular events (CVE, a composite of any stroke and transient ischemic attack) at long-term follow-up.
Primary Outcome
Defined as the composite of all-cause death, non-fatal MI, ornon-fatal stroke
Conditions Studied
Study Locations (2)
Florida
- UF Health - Gainesville
- UF Health - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,000 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2025-12-31 |
What the registry record for NCT06855394 still lists
NCT06855394 is an observational study that tracks outcomes without assigning an intervention. Its 13,000 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 11,988-participant average among 454 other Stroke trials with a reported enrollment target.
The record links to 7 conditions, with Stroke appearing as the primary indexed condition, and to 0 interventions.
NCT06855394 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06855394 about?
NCT06855394 is a clinical study titled "Genetic Testing of CYP2C19 in Prognostic Evaluation of Long-Term Major Adverse Cardiac and Vascular Events". Several studies have shown that the efficacy of clopidogrel for secondary prevention of major adverse cardiovascular events (MACE), including acute coronary syndrome, depends on the polymorphism of the CYP2C19 gene. However, studies with large sample sizes and long-term follow-up are missing. Moreov...
What is the current status of trial NCT06855394?
This trial is currently active not recruiting. The enrollment target is 13,000 participants. The study started on 2011-01-01. Estimated completion is 2025-12-31.
What conditions does trial NCT06855394 study?
This clinical trial studies the following conditions: Stroke, Heart Diseases, Coronary Arterial Disease (CAD), Venous Thromboembolic Disease, Atherosclerotic Vascular Disease.
Who is sponsoring clinical trial NCT06855394?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06855394 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06855394's enrollment target sits among peer trials
13,000 8th of 454 higher than 447 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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