Condition category
Circulatory System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Middeldorp

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Vascular Medicine
F4-276
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 5976
s.middeldorp@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

NOSTRADAMUS

Study hypothesis

Testing for thrombophilia after a first episode of Venous ThromboEmbolism (VTE) with subsequent prolongation of anticoagulant treatment in thrombophilic patients is beneficial in terms of clinical outcomes, quality of life, and costs.

Ethics approval

Approval received from the Medical Ethics Board of the Acamdemic Medical Center Amsterdam on September 20th 2006 (ref: MEC 06/216).

Study design

Randomised, controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pulmonary embolism, deep vein thrombosis

Intervention

Randomisation between disclosure and undisclosure of results of thrombophilia screening and subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the disclosure group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recurrent VTE 18 months after the acute episode of VTE.

Secondary outcome measures

1. Recurrent VTE at the end of the study
2. A composite endpoint of recurrent VTE and bleeding at the end of the study
3. Quality of life
4. Costs of testing and subsequent predefined prolongation of anticoagulant therapy

Overall trial start date

01/10/2006

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects must be willing and able to give written informed consent
2. Confirmed symptomatic Deep Vein Thrombosis (DVT), i.e., proximal vein or extensive calf-vein
thrombosis, involving at least the upper third part of the deep calf veins (trifurcation, and/or confirmed symptomatic Pulmonary Embolism (PE), no longer than two months prior to randomisation
3. Aged 18 years or older

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1336

Participant exclusion criteria

1. Previous episodes of DVT or PE
2. Active bleeding or high risk for bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH), fondaparinux or Vitamin K Antagonists (VKA)
3. Insertion of a caval filter to treat the episode of VTE
4. Active cancer or anti-cancer treatment in the six months prior to the acute episode of VTE
5. Life expectancy less than 18 months
6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome
7. Indications for VKA other than DVT

Recruitment start date

01/10/2006

Recruitment end date

01/04/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

Netherlands Heart Foundation (NHS, Nederlandse Hartstichting) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes