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Fiix-prothrombin Time for Monitoring Warfarin

NCT01565239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1156

Last updated 2014-09-09

No results posted yet for this study

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.

Conditions

  • Thromboembolism
  • Arterial
  • Venous

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Landspitali University Hospital

    lead OTHER

Principal Investigators

  • Pall T. Onundarson, M.D. · Landspitali and University of Iceland, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565239 on ClinicalTrials.gov