CClinicalTrials.gg
TerminatedNCT00206063Updated Nov 15, 2010

Long Term Open Follow-up With H376/95 vs. Warfarin

A Phase 2 interventional study of EXANTA in Stroke Prevention in Patients With Atrial Fibrillation, sponsored by AstraZeneca. Terminated at 19 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by AstraZeneca · Phase 2, Interventional, and Prevention

Why this study was terminated
Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.

02

Conditions studied

  • Stroke Prevention in Patients With Atrial Fibrillation

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 220 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed informed consent.
  • Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion criteria

Exclusion Criteria:

  • Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants

Interventions

  • DrugEXANTA

    Also known as: Ximelagatran

06

What researchers measure

Primary outcomes

  1. Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

07

Study locations

19 sites
  • Research Site
    Palo Alto, California, United States
  • Research Site
    Oostduinkerke, Belgium
  • Research Site
    Helsingor, Czech Republic
  • Research Site
    Most, Czech Republic
  • Research Site
    Plzeo, Czech Republic
  • Research Site
    Poibram, Czech Republic
  • Research Site
    Prague, Czech Republic
  • Research Site
    Arhus, Denmark
  • Research Site
    Odense, Denmark
  • Research Site
    Kuopio, Finland
  • Research Site
    Savonlinna, Finland
  • Research Site
    Hamar, Norway
  • Research Site
    Oslo, Norway
  • Research Site
    Plock, Poland
  • Research Site
    Siedice, Poland
  • Research Site
    Warsaw, Poland
  • Research Site
    Lund, Sweden
  • Research Site
    Leicester, United Kingdom
  • Research Site
    Newcastle, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00206063
Lead sponsor
AstraZeneca
First posted
Sep 21, 2005
Start date
Aug 1999
Primary completion
Jun 2004
Completion
Apr 2006
Last update
Nov 15, 2010
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion