Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01036646
Other study ID # BSTE-0125
Secondary ID
Status Completed
Phase N/A
First received December 17, 2009
Last updated February 8, 2013
Start date August 2009
Est. completion date September 2010

Study information

Verified date February 2013
Source Biosite
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date September 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults (18 years of age or older);

- Ability to read and speak English;

- Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);

- Target INR interval between 2.0 and 4.5

- Willing and able to provide written informed consent and comply with study procedures;

Exclusion Criteria:

- Hematocrit less than 25 or greater than 55%

- Lupus or antiphospholipid syndrome (APS)

- Already participated in this study

- A current INRatio PT Monitoring System User / Patient Self Tester

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Fox Valley Cardiology Aurora Illinois
United States Loma Linda VA Hospital Loma Linda California
United States UC Davis Healthcare System Sacramento California
United States San Diego Cardiac Center San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Biosite

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. 8 weeks No
See also
  Status Clinical Trial Phase
Completed NCT00603317 - Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid Phase 4
Completed NCT02533960 - Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
Completed NCT00596570 - Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting N/A
Not yet recruiting NCT05723926 - Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation N/A
Recruiting NCT05955365 - Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation Phase 4
Completed NCT02067182 - Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation Phase 4
Completed NCT04307225 - Atrial Fibrillation After CABG and PCI