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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01565239
Other study ID # Landspitali-1
Secondary ID
Status Completed
Phase Phase 2
First received March 22, 2012
Last updated September 8, 2014
Start date March 2012
Est. completion date February 2014

Study information

Verified date September 2014
Source Landspitali University Hospital
Contact n/a
Is FDA regulated No
Health authority Iceland: Ministry of Health and Social Security
Study type Interventional

Clinical Trial Summary

Experiments suggest that during treatment with vitamin K antagonists (VKA) the activity of coagulation factors (F) II and X better reflect anticoagulation than does FVII. Based on this a new prothrombin time based monitoring test (Fiix-PT) has been invented which is only sensitive to FII and FX. The Fiix-PT can be converted to INR ("Fiix-INR").

The investigators hypothesize that the Fiix-PT may reflect anticoagulation and the antithrombotic effect of VKA as accurately or better than the current PT based tests do (INR based on PT or P&P). The protocol describes a prospective randomized double-blind trial that will be conducted at the Landspitali Anticoagulation Management Center (AMC).

The objective of the protocol is to evaluate the efficacy and safety of Fiix-INR as a monitoring test compared to the current PT based assays (INR) used to monitor patients treated with VKA to prevent thromboembolism. The investigators will randomize 1200 clients of the AMC into two identically sized monitoring groups, Fiix-INR (test group) and INR (control group).

The clinical endpoints to be studied include efficacy (arterial and venous thromboembolic event rate) and safety (bleeding events). Additionally, surrogate convenience endpoints will be studied such as test frequency and time within target range.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Fiix prothrombin time
The Fiix prothrombin time (or Stuart-prothrombin time) is a new modification of the currently used prothrombin times. The Fiix PT as opposed to PT is sensitive to the activity of coagulation factors II and X only whereas the PT is sensitive to factors I, II, V, VII and X.

Locations

Country Name City State
Iceland Landspitali University Hospital Reykjavik N.a.

Sponsors (2)

Lead Sponsor Collaborator
Landspitali University Hospital University of Rochester

Country where clinical trial is conducted

Iceland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thromboembolic events 7.2.2 Primary Efficacy criteria
The following definitions will be applied by the IAC to confirm a suspected episode of symptomatic recurrent TE:
Venous thromboembolism (VTE).
All objectively diagnosed VTE (by imaging technology or autopsy) will be included
Superficial thromboses will not be included
Arterial thromboembolism (ATE)
All objectively confirmed ATE (by imaging techniques, surgically, autopsy, EKG etc) will be included
Transient ischemic attacks of any kind (TIA´s, RIND´s) will be included
1200 patients years of observation time, 18 months on average for each participant No
Primary Major hemorrhage 7.2.3 Safety outcome criteria The principal safety outcome is clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding).
Additional safety outcomes include all deaths and other vascular events. 7.2.3.1 Bleeding definitions All suspected bleedings will be reported and will be classified by the IAC as major, clinically relevant non-major, trivial, or no bleeding.
Major bleeding see ISTH criteria JTH 2005;3:692-4
1200 patient years of observation, 18 months on average for each study participant Yes
Secondary Monitoring test frequency and time spent within target range We will compare the following in the test group and the control group:
i. Total number of tests per treatment year ii. Dose adjustment frequency (interval or number of dose adjustments during observation period) iii. Percent tests within treatment range over observation period iv. Percent time within target range (TTR) over observation period
1200 patients years of observation No
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