Condition category
Circulatory System
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
25/03/2014
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 Susan Rebecca Kahn

ORCID ID

Contact details

Center for Clinical Epidemiology and Community Studies
SMBD Jewish General Hospital
3755 Cote Ste. Catherine Rm A-127
Montreal
Quebec
H3T 1E2
Canada
+1 514 3408222 (4667)
susan.kahn@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00143598

Protocol/serial number

MCT-63142

Study information

Scientific title

Compression stockings to prevent post-thrombotic syndrome: a multicentre, two arm, placebo-controlled randomised parallel device trial

Acronym

SOX

Study hypothesis

To determine whether Elastic Compression Stockings (ECS) used for two years are effective in preventing the Post-Thrombotic Syndrome (PTS) in patients with symptomatic proximal Deep Venous Thrombosis (DVT).

Please note that in 2005, the intervention using Celecoxib was removed from this trial due to reports of negative effects in a large colorectal cancer prevention clinical trial. Thus, the SOX Trial protocol was amended to take this into account. The most recent changes to the protocol were made to this trial record on the 10th June 2009.

Previous hypothesis:
To determine whether Elastic Compression Stockings (ECS) used for two years, and celecoxib, a COX-II inhibitor, used for 30 days are effective in preventing the Post-Thrombotic Syndrome (PTS) in patients with symptomatic proximal Deep Venous Thrombosis (DVT).

As of 17/02/2010 this record has been updated to include an extended anticipated end date; the intial anticipated end date of this record was 30/12/2011. Please note that enrolment to this trial is now completed.

Sub -study registered with ClinicalTrials.gov: NCT01615705 - Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial (Bio-SOX)

Sub -study registered with ClinicalTrials.gov: NCT01615692 - The 36-month Extension to Follow up Sub Study

Ethics approval

1. Canada: The Research Ethics Committee of Sir Mortimer B Davis Jewish General Hospital approved on the 30th July 2003. This ethics approval was amended on the 27th January 2005 to take into account the removal of the celecoxib intervention and consequent protocol changes.
2. USA: The University of Oklahoma Health Sciences Center Institutional Review Board (USA) approved on the 31st July 2007 (ref: 13513). All other centres subsequent to this in the USA will require full ethics approval before recruiting participants.

Study design

Multicentre, two arm, placebo randomised parallel device trial with study participant, study investigator, and outcome assessor blinded.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Deep vein thrombosis

Intervention

Current interventions (protocol updated in January 2005):
1. Experimental interventions: knee-length, 30 - 40 mmHg (Class II), graduated ECS worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years
2. Control interventions: knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years

Due to the removal of the Celecoxib intervention, the recruitment resumed in February 2005, and the anticipated end date of this trial has now been extended by one year to 30th December 2011 (amended 10/06/2009). The previous anticipated end date of this trial was 30/03/2008 (amended 13/05/2008).

Contact for public queries as of 13/05/2008:
Susan Kahn MD, MSc
SOX Trial Principal Investigator
SMBD Jewish General Hospital
Phone: +1 514 340 8222 ext. 4667
Fax: +1 514 340 7564
E-mail: susan.kahn@mcgill.ca

Previous interventions:
1. Experimental interventions:
1.1. Knee-length, 30 - 40 mmHg (Class II), graduated ECS worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years
1.2. Celecoxib, 200 mg orally (po) twice a day (BID), begun on the day of DVT diagnosis and continued for 30 days
2. Control interventions:
2.1. Knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years
2.2. Placebo, identical in appearance to celecoxib, one tablet po BID, begun on the day of DVT diagnosis and continued for 30 days

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of post-thrombotic syndrome (PTS) at two years.

Secondary outcome measures

Current secondary outcome measures (protocol updated in January 2005)
1. Severity of PTS at two years follow up, including incidence of venous ulcer
2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years
3. C-reactive protein at 30 days compared to baseline value
4. Quality of life over the two-year follow up
5. Cost-effectiveness

Previous secondary outcome measures:
1. Severity of PTS at two years follow up, including incidence of venous ulcer
2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years
3. Incidence of major bleeding or arterial thrombotic events during the first 60 days
4. C-reactive protein at 30 days compared to baseline value
5. Quality of life over the two-year follow up
6. Cost-effectiveness

Overall trial start date

01/04/2003

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria (protocol updated in August 2008):
Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Previous inclusion criteria (January 2005):
Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 10 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Initial inclusion criteria (January 2004):
Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 72 hours (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

Current exclusion criteria (protocol updated in January 2005):
1. Contraindication to compression stockings
2. Limited lifespan (estimated less than six months)
3. Geographic inaccessibility preventing return for follow-up visits
4. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
5. Treatment of acute DVT with thrombolytic agents

Previous exclusion criteria:
1. Contraindication to compression stockings
2. Contraindication to celecoxib
3. History of warfarin, aspirin or Non-Steroidal Anti-Inflammatory Drug (NSAID)-associated major haemorrhagic event
4. Regular, daily use of NSAIDs
5. Inability/unwillingness to stop anti-platelet drugs for 30 days
6. Limited lifespan (estimated less than six months)
7. Geographic inaccessibility preventing return for follow-up visits
8. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
9. Treatment of acute DVT with thrombolytic agents

Recruitment start date

01/04/2003

Recruitment end date

31/01/2012

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

Center for Clinical Epidemiology and Community Studies
Montreal, Quebec
H3T 1E2
Canada

Sponsor information

Organisation

Sir Mortimer B. Davis Jewish General Hospital-Mtl (Canada)

Sponsor details

3755 Côte Ste-Catherine Road
Montreal
Quebec
H3T 1E2
Canada
+1 514 340 8222
wainberg@ldi.jgh.mcgill.ca

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63142)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

SIGVARIS Corp. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17711595
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24315521

Publication citations

  1. Protocol

    Kahn SR, Shbaklo H, Shapiro S, Wells PS, Kovacs MJ, Rodger MA, Anderson DR, Ginsberg JS, Johri M, Tagalakis V, , Effectiveness of compression stockings to prevent the post-thrombotic syndrome (the SOX Trial and Bio-SOX biomarker substudy): a randomized controlled trial., BMC Cardiovasc Disord, 2007, 7, 21, doi: 10.1186/1471-2261-7-21.

  2. Results

    Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS, , Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial., Lancet, 2014, 383, 9920, 880-888, doi: 10.1016/S0140-6736(13)61902-9.

Additional files

Editorial Notes