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
-
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.
-
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.