NCT00206063

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_2

Geographic Reach
9 countries

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

Stroke Prevention in Patients With Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

Interventions

EXANTADRUG
Also known as: Ximelagatran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Palo Alto, California, United States

Location

Research Site

Oostduinkerke, Belgium

Location

Research Site

Helsingor, Czechia

Location

Research Site

Most, Czechia

Location

Research Site

Plzeo, Czechia

Location

Research Site

Poibram, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Aarhus, Denmark

Location

Research Site

Odense, Denmark

Location

Research Site

Kuopio, Finland

Location

Research Site

Savonlinna, Finland

Location

Research Site

Hamar, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Płock, Poland

Location

Research Site

Siedice, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Lund, Sweden

Location

Research Site

Leicester, United Kingdom

Location

Research Site

Newcastle, United Kingdom

Location

MeSH Terms

Interventions

ximelagatran

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 1999

Primary Completion

June 1, 2004

Study Completion

April 1, 2006

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

NO(2)PL(3)DK(2)CZ(5)SE(1)FI(2)GB(2)US(1)BE(1)