Distal (Calf) Deep-vein ThrombosisPhase 3CACTUS-PTSNCT00421538
Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)
A Phase 3 study testing nadroparine calcium in people with Distal (Calf) Deep-vein Thrombosis, run by University Hospital, Geneva at 7 sites in 3 countries.
Trial summary
CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal (Calf) Deep-vein Thrombosis
- What is being tested?
- nadroparine calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jan 2008to Aug 2015
- 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
- All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.
Who cannot join
- Age less than 18 years
- Previously objectively diagnosed DVT or PE
- Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation)
- Clinically suspected pulmonary embolism
- Active cancer, receiving cancer treatment or cancer considered cured for <6 months
- Ipsilateral or contralateral proximal DVT
Show all 18Show fewer
- Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...)
- Pregnancy
- Thrombocytopenia (platelet count < 100 g/l)
- Impaired renal function (serum creatinine > 180 micromol/l or clearance to creatinine less than 30 ml/min)
- Known hypersensitivity to heparin
- Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (gastric ulcer, cerebral malignant disease...)
- Treatment with daily NSAIDs (aspirin ≤160 mg/day permitted)
- Body weight >115 kg or <40 kg
- Treatment with therapeutic doses of anticoagulants for >2 days, corresponding to: 2 injections of LMWH if once daily therapeutic LMWH used; 3 injections of LMWH if twice-daily therapeutic LMWH used; 1 dose of oral vitamin K antagonist (e.g. warfarin)
- Ongoing requirement for prophylactic dose thromboprophylaxis (e.g. acute post-op patient receiving thromboprophylaxis)
- Enrolled in another clinical trial within previous 30 days
- Inability or refusal to provide informed consent
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Royal University Hospital
Saskatoon, Saskatchewan
About this study
Official title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography
CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.
Read the detailed description
The CACTUS-PTS study will compare anticoagulant treatment for 6 weeks versus placebo in acute, symptomatic distal DVT. Patients will be randomized to receive either a six-week period of LMWH at therapeutic dosage or a six-week period of placebo. All patients will be treated with elastic compression stockings and followed-up with a standardized ultrasonography protocol. Strict ultrasonographic diagnostic criteria for distal DVT have been defined. Control compression ultrasonography will be performed between days 3 and 7 and at six weeks after inclusion. The primary outcome will be a composite of the proportion of patients with extension of the thrombus to the proximal veins (detected by the programmed ultrasound examinations or by an ultrasound performed because of recurrent symptoms) or symptomatic PE in both arms of the study during the 6-weeks study period. Patients with such an outcome will be anticoagulated as currently admitted in presence of a proximal DVT. Secondary outcomes will be the individual components of the composite endpoint (distal DVT extension to proximal veins; symptomatic PE), major bleeding, serious adverse events and death reported at 6 weeks and 90 days. To answer the research question of the PTS add-on study, patients will self-assess and be assessed for PTS by a clinician using the Villalta scale, 1 year following their enrolment into the trial. In addition, patients will complete a Quality of Life (QOL) questionnaire. The QOL questionnaire will be comprised of both the VEINES-QOL and SF-36. The primary outcome is the rate of PTS, with secondary outcomes of QOL scores and PTS severity.
- Conditions
- Distal (Calf) Deep-vein Thrombosis
- Being tested
- nadroparine calcium, Placebo
- Keywords
- Deep vein Thrombosis, Calf vein thrombosis, Low-molecular weight heparin, Placebo, Elastic contention, Compression Ultrasonography
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nadroparine calciumDrug
Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.
PlaceboDrug
Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| LMWH | Active comparator | Therapeutic dose of Nadroparin Receives: Drug: nadroparine calcium |
| Placebo | Placebo comparator | Injectable placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks
Measured: 6 weeks
Rate of post-thrombotic syndrome (PTS)
Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.
Measured: 1 year
Secondary outcomes (6)
Individual components of the composite endpoint: distal DVT extension to proximal veins at 6 weeks and 90 days; PE at 6 weeks and 90 days
Measured: 6 weeks and 3 months
Major bleeding at 6 weeks and 90 days
Measured: 6 weeks and 3 months
Death at 6 weeks and 90 days
Measured: 6 weeks and 3 months
Serious adverse events at 6 weeks and 90 days
Measured: 6 weeks and 3 months
Generic and venous disease-specific Quality of Life scores
Measured: 1 year
PTS severity category
Can either be mild, intermediate, severe
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal (Calf) Deep-vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Ministry of Health, France, Lady Davis Institute, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marc Righini, University Hospital, Geneva
- Investigators
- Marc Righini, MD, Principal investigator, University Hospital, GenevaIsabelle Quéré, MD, Principal investigator, University Hospital, MontpellierSusan Kahn, MD, Principal investigator, Jewish General HospitalMarc Carrier, MD, Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421538
- Sponsor's protocol ID
- 3200B0-105991
- Other IDs
- CACTUS-PTS Trial
- Acronym
- CACTUS-PTS
- Status last verified
- May 2018
- First submitted
- 11 Jan 2007
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Righini M, Robert-Ebadi H, Glauser F, Blondon M, Ouvry P, Diamand JM, Tissot A, Frappe P, Quere I, Kahn SR, Galanaud JP, Le Gal G. Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial. J Thromb Haemost. 2019 Mar;17(3):507-510. doi: 10.1111/jth.14387. Epub 2019 Feb 3.
PubMed 30656824Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, Barrellier MT, Hamel-Desnos C, Jurus C, Pichot O, Martin M, Mazzolai L, Choquenet C, Accassat S, Robert-Ebadi H, Carrier M, Le Gal G, Mermilllod B, Laroche JP, Bounameaux H, Perrier A, Kahn SR, Quere I. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016 Dec;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4. Epub 2016 Nov 8.
PubMed 27836513Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30.
PubMed 22648486
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography
- ClinicalTrials.gov ID
- NCT00421538
- Acronym / sponsor ID
- CACTUS-PTS / 3200B0-105991
- Conditions
- Distal (Calf) Deep-vein Thrombosis
- Keywords
- Deep vein Thrombosis, Calf vein thrombosis, Low-molecular weight heparin, Placebo, Elastic contention, Compression Ultrasonography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Ministry of Health, France, Lady Davis Institute, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2008 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jan 2007 (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.
CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.
Detailed description
The CACTUS-PTS study will compare anticoagulant treatment for 6 weeks versus placebo in acute, symptomatic distal DVT. Patients will be randomized to receive either a six-week period of LMWH at therapeutic dosage or a six-week period of placebo. All patients will be treated with elastic compression stockings and followed-up with a standardized ultrasonography protocol. Strict ultrasonographic diagnostic criteria for distal DVT have been defined. Control compression ultrasonography will be performed between days 3 and 7 and at six weeks after inclusion. The primary outcome will be a composite of the proportion of patients with extension of the thrombus to the proximal veins (detected by the programmed ultrasound examinations or by an ultrasound performed because of recurrent symptoms) or symptomatic PE in both arms of the study during the 6-weeks study period. Patients with such an outcome will be anticoagulated as currently admitted in presence of a proximal DVT. Secondary outcomes will be the individual components of the composite endpoint (distal DVT extension to proximal veins; symptomatic PE), major bleeding, serious adverse events and death reported at 6 weeks and 90 days. To answer the research question of the PTS add-on study, patients will self-assess and be assessed for PTS by a clinician using the Villalta scale, 1 year following their enrolment into the trial. In addition, patients will complete a Quality of Life (QOL) questionnaire. The QOL questionnaire will be comprised of both the VEINES-QOL and SF-36. The primary outcome is the rate of PTS, with secondary outcomes of QOL scores and PTS severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH | Active comparator | Drug: nadroparine calciumTherapeutic dose of Nadroparin |
| Placebo | Placebo comparator | Drug: PlaceboInjectable placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.
Key exclusion criteria (18 listed)
- Age less than 18 years
- Previously objectively diagnosed DVT or PE
- Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation)
- Clinically suspected pulmonary embolism
- Active cancer, receiving cancer treatment or cancer considered cured for <6 months
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 |
|---|---|---|
| nadroparine calciumOnce-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks. | Drug | LMWH |
| PlaceboOnce-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks | Drug | Placebo |
Primary outcome
Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks
Time frame: 6 weeks
Rate of post-thrombotic syndrome (PTS)
Time frame: 1 year
Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.
6 secondary outcomes
Individual components of the composite endpoint: distal DVT extension to proximal veins at 6 weeks and 90 days; PE at 6 weeks and 90 days
Time frame: 6 weeks and 3 months
Major bleeding at 6 weeks and 90 days
Time frame: 6 weeks and 3 months
Death at 6 weeks and 90 days
Time frame: 6 weeks and 3 months
Serious adverse events at 6 weeks and 90 days
Time frame: 6 weeks and 3 months
Generic and venous disease-specific Quality of Life scores
Time frame: 1 year
PTS severity category
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 30656824Righini M, Robert-Ebadi H, Glauser F, Blondon M, Ouvry P, Diamand JM, Tissot A, Frappe P, Quere I, Kahn SR, Galanaud JP, Le Gal G. Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial. J Thromb Haemost. 2019 Mar;17(3):507-510. doi: 10.1111/jth.14387. Epub 2019 Feb 3.
- Derived from this study: PubMed 27836513Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, Barrellier MT, Hamel-Desnos C, Jurus C, Pichot O, Martin M, Mazzolai L, Choquenet C, Accassat S, Robert-Ebadi H, Carrier M, Le Gal G, Mermilllod B, Laroche JP, Bounameaux H, Perrier A, Kahn SR, Quere I. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016 Dec;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4. Epub 2016 Nov 8.
- Derived from this study: PubMed 22648486Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30.
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Deep Vein Thrombosis
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.
Marc Righini, MD principal investigator
University Hospital, Geneva
Isabelle Quéré, MD principal investigator
University Hospital, Montpellier
Susan Kahn, MD principal investigator
Jewish General Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nadroparine calcium in people with Distal (Calf) Deep-vein Thrombosis, run by University Hospital, Geneva at 7 sites in 3 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 1 inclusion and 18 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: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, France, Switzerland. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT00421538, which also lists 3 linked publications.
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 4 May 2018.