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NCT02345356 · ClinicalTrials.gov registry record
A Genomic Approach to Warfarin Dose Prescription in Admixed Caribbean Hispanics
A clinical trial of Atrial Fibrillation and Pulmonary Embolism, sponsored by University of Puerto Ri.
- Completed
- Registry status
- 200
- Enrollment target
- 3
- Study locations
NCT02345356: Completed study of Atrial Fibrillation and Pulmonary Embolism, sponsored by University of Puerto Ri.
NCT02345356 is a study of Atrial Fibrillation and Pulmonary Embolism that has completed, run by University of Puerto Ri. The registered enrollment target is 200 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02345356, a study of Atrial Fibrillation and Pulmonary Embolism, has completed, sponsored by University of Puerto Ri.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 3
- Study locations
Study Summary
Caribbean Hispanics are a population with a disproportionately high prevalence of cardio-metabolic disorders but with a limited expectation of benefits from current pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription guidelines for this population, who have arisen from European, West African and Amerindian genomic origins to produce a highly heterogeneous population. Our project combines admixture analysis and DNA-sequencing with development of more accurate rules for better predictability of warfarin dosing to immediately serve this medically underserved population.
Primary Outcome
percentage of time each patient spent within and out of the therapeutic range (TTR) during initiation, using the Rosendaal linear interpolation method.
Conditions Studied
Interventions
- GENETIC Genotype-guided
- OTHER Standard-of-Care
Study Locations (3)
Other
- UPR University Hospital at Carolina - Carolina
- UDH University Hospital at Centro Medico - San Juan
Florida
- Miami VA Healthcare System - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2016-01 |
| Est. Completion | 2022-05-17 |
What the finished NCT02345356 record still lists
NCT02345356 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Genotype-guided is the first listed.
NCT02345356 reports a single indexed study location in Other, Florida.
Frequently Asked Questions
What is clinical trial NCT02345356 about?
NCT02345356 is a clinical study titled "A Genomic Approach to Warfarin Dose Prescription in Admixed Caribbean Hispanics". Caribbean Hispanics are a population with a disproportionately high prevalence of cardio-metabolic disorders but with a limited expectation of benefits from current pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The investigators focus on warfarin responses to dev...
What is the current status of trial NCT02345356?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2016-01. Estimated completion is 2022-05-17.
What conditions does trial NCT02345356 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis, Cardiac Valvular Insufficiency, Coagulopathies.
What interventions are being tested in trial NCT02345356?
The interventions under investigation include: Genotype-guided (GENETIC), Standard-of-Care (OTHER).
Who is sponsoring clinical trial NCT02345356?
This trial is sponsored by University of Puerto Ri, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02345356 being conducted?
This trial has 3 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 NCT02345356's enrollment target sits among peer trials
200 101st of 202 higher than 97 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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