ThromboembolismPhase 3EXTENDNCT00206089
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
A Phase 3 study testing EXANTA in people with Thromboembolism, run by AstraZeneca at 125 sites in 16 countries.
Trial summary
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- EXANTA
- How many people
- 3,300 participants
- Where
- 125 sitesin 16 countries
- Study dates
- Sep 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Female or male aged 18 years and over
- Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.
Who cannot join
- History of heparin-induced thrombocytopenia
- Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.
- Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.
Trial locations and contacts
125 sites in 16 countries.
125 sites in 16 countries
Norway17 sites
Research Site
Ålesund
Research Site
Bergen
Research Site
Bodø
Research Site
Drammen
Research Site
Elverum
Research Site
Gjettum
Research Site
Hagavik
Research Site
Kongsberg
Research Site
Kongsvinger
Research Site
Larvik
Research Site
Levanger
Research Site
Lillehammer
Research Site
Nordbyhagen
Research Site
Oslo
Research Site
Skien
Research Site
Stavanger
Research Site
Trondheim
Sweden15 sites
Research Site
Borås
Research Site
Falköping
Research Site
Falun
Research Site
Gothenburg
Research Site
Jönköping
Research Site
Kalmar
Research Site
Kungälv
Research Site
Linköping
Research Site
Lund
Research Site
Mölndal
Research Site
Örebro
Research Site
Skövde
Research Site
Stockholm
Research Site
Uddevalla
Research Site
Uppsala
Denmark10 sites
Research Site
Aarhus
Research Site
Glostrup Municipality
Research Site
Hellerup
Research Site
Herlev
Research Site
Hillerød
Research Site
Holstebro
Research Site
Hørsholm
Research Site
Hvidovre
Research Site
Silkeborg
Research Site
Vejle
Austria9 sites
Research Site
Graz
Research Site
Innsbruck
Research Site
Leoben
Research Site
Neunkirchen
Research Site
Neustadt
Research Site
Sankt Johann in Tirol
Research Site
Viborg
Research Site
Vienna
Research Site
Wels
France9 sites
Research Site
Amiens
Research Site
Annecy
Research Site
Caen
Research Site
Créteil
Research Site
Le Kremlin-Bicêtre
Research Site
Montpellier
Research Site
Nice
Research Site
Paris
Research Site
Saint-Etienne
Germany9 sites
Research Site
Bad Mergentheim
Research Site
Düsseldorf
Research Site
Essen
Research Site
Frankfurt
Research Site
Garmisch-Partenkirchen
Research Site
Halle
Research Site
Rheinfelden
Research Site
Sommerfeld
Research Site
Wiesbaden
Netherlands8 sites
Research Site
Assen
Research Site
Breda
Research Site
Groningen
Research Site
Hilversum
Research Site
Leeuwarden
Research Site
Sittard
Research Site
Zaandam
Research Site
Zwolle
Poland8 sites
Research Site
Biaystok
Research Site
Bydgoszcz
Research Site
Chojnice
Research Site
Gdansk
Research Site
Lublin
Research Site
Od
Research Site
Warsaw
Research Site
Wrocraw
Hungary7 sites
Research Site
Budapest
Research Site
Gyula
Research Site
Gyzr
Research Site
Kecskemét
Research Site
Pécs
Research Site
Szeged
Research Site
Székesthérvár
Portugal7 sites
Research Site
Barreiro
Research Site
Cascais
Research Site
Lisbon
Research Site
Parede
Research Site
Setúbal
Research Site
Torres Vedras
Research Site
Vila Franca de Xira
Finland6 sites
Research Site
Hus
Research Site
Jyväskylä
Research Site
Kuopio
Research Site
Oys
Research Site
Tampere
Research Site
Turku
Switzerland6 sites
Research Site
Basel
Research Site
Bern
Research Site
Geneva
Research Site
Lugano
Research Site
Luzem
Research Site
Zurich
Spain5 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Ourense
Research Site
Santander
Research Site
Valencia
Mexico3 sites
Research Site
Estado de México
Research Site
Guadalajara
Research Site
Mexico City
South Africa3 sites
Research Site
Durban
Research Site
Gauteng
Research Site
Sandton
About this study
Official title: The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.
- Conditions
- Thromboembolism
- Being tested
- EXANTA
- Keywords
- Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXANTADrug
Also called Melagatran/Ximelagatran
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority for the prevention of VTE or VTE related death
Secondary outcomes (2)
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3,300 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206089
- Sponsor's protocol ID
- D4003C00030
- Acronym
- EXTEND
- Status last verified
- Nov 2010
- First submitted
- 13 Sep 2005
- Last updated
- 15 Nov 2010
- Results posted
- No
Publications
Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.
PubMed 18485453
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT00206089
- Acronym / sponsor ID
- EXTEND / D4003C00030
- Conditions
- Thromboembolism
- Keywords
- Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
- Enrolment
- 3,300 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent,
- Female or male aged 18 years and over
- Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.
Key exclusion criteria (3 listed)
- History of heparin-induced thrombocytopenia
- Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.
- Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXANTAAlso: Melagatran/Ximelagatran | Drug | – |
Primary outcome
Non-inferiority for the prevention of VTE or VTE related death
2 secondary outcomes
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Safety
Results and safety
The study was stopped early (reason given: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Derived from this study: PubMed 18485453Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Medical Science Director, MD study director
AstraZeneca
125 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EXANTA in people with Thromboembolism, run by AstraZeneca at 125 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in Norway, Sweden, Denmark, Austria, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority for the prevention of VTE or VTE related death. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.