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NCT01037270 · ClinicalTrials.gov registry record

Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

A clinical trial of Atrial Fibrillation and Pulmonary Embolism, sponsored by Abbott RDx Cardiometabolic.

Completed
Registry status
271
Enrollment target
4
Study locations

NCT01037270 is a study of Atrial Fibrillation and Pulmonary Embolism that has completed, run by Abbott RDx Cardiometabolic. The registered enrollment target is 271 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT01037270, a study of Atrial Fibrillation and Pulmonary Embolism, has completed, sponsored by Abbott RDx Cardiometabolic.

COMPLETED
Registry status
271 participants
Enrollment target
4
Study locations

Study Summary

This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.

Conditions Studied

Atrial Fibrillation Pulmonary Embolism Deep Vein Thrombosis

Study Locations (4)

California

  • Loma Linda VA Hospital - Loma Linda
  • UC Davis Healthcare System - Sacramento
  • San Diego Cardiac Center - San Diego

Illinois

  • Fox Valley Cardiology - Aurora

Trial Details

FieldValue
Enrollment Target 271 participants
Start Date 2009-08
Est. Completion 2010-06

Sponsor

Abbott RDx Cardiometabolic

14 total trials

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What the Registry Record Tells You About NCT01037270

The ClinicalTrials.gov registry entry for NCT01037270 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower). The listed sponsor is Abbott RDx Cardiometabolic, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 0 interventions.

NCT01037270 reports 4 study locations spanning 2 distinct geographic areas - top geographies include California, Illinois.

Frequently Asked Questions

What is clinical trial NCT01037270 about?

NCT01037270 is a clinical study titled "Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity". This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative deter...

What is the current status of trial NCT01037270?

This trial is currently completed. The enrollment target is 271 participants. The study started on 2009-08. Estimated completion is 2010-06.

What conditions does trial NCT01037270 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis.

Who is sponsoring clinical trial NCT01037270?

This trial is sponsored by Abbott RDx Cardiometabolic, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01037270 being conducted?

This trial has 4 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.