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NCT04580589 · ClinicalTrials.gov registry record
DOAC ADRs Retrospective Study on Genetic Variations
A clinical trial of Drug-Related Side Effects and Adverse Reactions and Treatment Failure, sponsored by Cipherome.
- Completed
- Registry status
- 210
- Enrollment target
- 1
- Study location
NCT04580589: Completed study of Drug-Related Side Effects and Adverse Reactions and Treatment Failure, sponsored by Cipherome.
NCT04580589 is a study of Drug-Related Side Effects and Adverse Reactions and Treatment Failure that has completed, run by Cipherome. The registered enrollment target is 210 participants, roughly in line with the 211-participant average among 4 other Drug-Related Side Effects and Adverse Reactions trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580589, a study of Drug-Related Side Effects and Adverse Reactions and Treatment Failure, has completed, sponsored by Cipherome.
- COMPLETED
- Registry status
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the blood vessels.
Primary Outcome
* Reduction in hemoglobin of at least 2 g/dL * Blood loss requiring transfusion of at least 2 units of whole blood or erythrocytes * Critical anatomical sites of bleeding: intramuscular with compartment syndrome, intracranial, intraspinal, retroperitoneal, intraocular, pericardial, and atraumatic intra-articular bleeding. * Bleeding leading to death
Conditions Studied
Study Locations (1)
California
- Santa Clara Valley Medical Center - Santa Clara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-10-31 |
What the finished NCT04580589 record still lists
NCT04580589 is an observational study that tracks outcomes without assigning an intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 211-participant average among 4 other Drug-Related Side Effects and Adverse Reactions trials with a reported enrollment target.
The record links to 2 conditions, with Drug-Related Side Effects and Adverse Reactions appearing as the primary indexed condition, and to 0 interventions.
NCT04580589 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04580589 about?
NCT04580589 is a clinical study titled "DOAC ADRs Retrospective Study on Genetic Variations". The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the...
What is the current status of trial NCT04580589?
This trial is currently completed. The enrollment target is 210 participants. The study started on 2021-02-01. Estimated completion is 2022-10-31.
What conditions does trial NCT04580589 study?
This clinical trial studies the following conditions: Drug-Related Side Effects and Adverse Reactions, Treatment Failure.
Who is sponsoring clinical trial NCT04580589?
This trial is sponsored by Cipherome, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580589 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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