NeoplasmPhase 4NCT01708850
Study in Cancer Patients With Central Line Associated Clots in the Upper Extremity Treated With Rivaroxaban (Catheter 2)
A Phase 4 study testing Rivaroxaban in people with Neoplasm and Central Venous Catheter Thrombosis, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
Patients with cancer and an upper extremity DVT associated with a central venous catheter (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes including bleeding and recurrent venous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Central Venous Catheter Thrombosis
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jun 2016
- Phase
- Phase 4
- 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
- Male or female > 18 years of age.
- Symptomatic acute upper limb thrombosis in the axillary, subclavian, innominate or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or CT scan.
- Diagnosis of active malignancy (other than non-melanoma skin cancer), defined as patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
- Willing to provide written informed consent.
Who cannot join
- Dialysis catheters.
- Active bleeding or high risk for major bleeding.
- Platelet Count < 75 x 109/L.
- Creatinine Clearance < 30 mL/min.
- Currently on other anticoagulant with therapeutic intent for another indication.*
- Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement.
Show all 12Show fewer
- Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (ie. 2 mg tPA).
- Patients with AML, ALL or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months.
- Thrombosis involving the brachial or cephalic veins only.
- Treatment for current episode > 7 days with any acceptable anticoagulant therapy.
- Concomitant use of P-glycoprotein and CYP3A4 inhibitors (ie. azole antifungals such as ketoconazole) or inducers (ie. rifampicin, antiepileptics).*
- Recent coronary artery stent requiring dual anti-platelet therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2)
Patients with cancer and an upper extremity DVT associated with a central venous catheter (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes including bleeding and recurrent venous thromboembolism.
The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT secondary to central venous catheters in patients with active malignancy is an effective therapy as quantified by the success of catheter preservation. Prolonged line salvage rate without recurrence of UEDVT will improve the management of cancer patients who develop an upper extremity deep venous thrombosis in the setting of a central venous catheter.
Read the detailed description
This will be a prospective cohort study of patients who present with an acute upper limb thrombosis in the setting of a central venous catheter. The total study duration will be 12 weeks, with one follow up telephone visit at 6 months. All patients will be treated with rivaroxaban at a dose of 15 mg orally twice daily for three weeks, followed by 20 mg daily. Anticoagulation will continue for three months regardless of the length of time the catheter is in place. Continuation of anticoagulation beyond this time period is at the discretion of the investigators.
Strengths of this study include its prospective cohort format, and access to a large oncologic population through the London Regional Cancer Program and other corresponding centres. In addition, The Catheter Study looking at CVC survival and safety in patients with cancer diagnosed with UEDVT and treated with a bridging protocol of warfarin/dalteparin was organized primarily through the LHSc and results therein could be directly compared to the results from this study given the similar patient population.
Limitations of this study include the small sample size and the fact that there is no LMWH monotherapy comparison group. In addition, this will be an open study with no blinding, given the nature of line survival. There is also the chance that a proportion of patients will have their catheters removed for other reasons, such as finishing treatment or personal preference, which could affect the validity of survival results.
This design was selected given the small number of patients presenting with this diagnosis each year at our centre, which would present difficulty in accruing enough patients for several comparisons group. Results will be compared to the Catheter Study and previous literature.
- Conditions
- Neoplasm, Central Venous Catheter Thrombosis
- Being tested
- Rivaroxaban
- Medical subject headings
- Neoplasms, Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
All specified in arm description. One arm study.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Other | Rivaroxaban 15 mg po bid x 3 weeks, followed by rivaroxaban 20 mg po daily x 9 weeks. Then up to discretion of investigator to decide regarding further anticoagulation as study length is limited to 12 weeks. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA.
The primary endpoint of the study will be proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA, within the 3 months of study follow-up.
Measured: 12 weeks
Secondary outcomes (5)
Recurrence of DVT or PE
Measured: 12 weeks
Major Bleeding
Measured: 12 weeks
Clinically Relevant Non-Major Bleeding
Measured: 12 weeks
Death
Measured: 12 weeks
Time to Central Line Failure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2016
- Study completionJun 2016
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 NeoplasmStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwynivere Davies, London Health Sciences Centre
- Investigators
- Dr. Michael J. Kovacs, MD, FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708850
- Sponsor's protocol ID
- Catheter 2
- Status last verified
- Sep 2016
- First submitted
- 15 Oct 2012
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovacs MJ, Kahn SR, Rodger M, Anderson DR, Andreou R, Mangel JE, Morrow B, Clement AM, Wells PS. A pilot study of central venous catheter survival in cancer patients using low-molecular-weight heparin (dalteparin) and warfarin without catheter removal for the treatment of upper extremity deep vein thrombosis (The Catheter Study). J Thromb Haemost. 2007 Aug;5(8):1650-3. doi: 10.1111/j.1538-7836.2007.02613.x. Epub 2007 May 7.
PubMed 17488349
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2)
- ClinicalTrials.gov ID
- NCT01708850
- Acronym / sponsor ID
- Catheter 2
- Conditions
- Neoplasm, Central Venous Catheter Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2012 (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.
Patients with cancer and an upper extremity DVT associated with a central venous catheter (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes including bleeding and recurrent venous thromboembolism.
The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT secondary to central venous catheters in patients with active malignancy is an effective therapy as quantified by the success of catheter preservation. Prolonged line salvage rate without recurrence of UEDVT will improve the management of cancer patients who develop an upper extremity deep venous thrombosis in the setting of a central venous catheter.
Detailed description
This will be a prospective cohort study of patients who present with an acute upper limb thrombosis in the setting of a central venous catheter. The total study duration will be 12 weeks, with one follow up telephone visit at 6 months. All patients will be treated with rivaroxaban at a dose of 15 mg orally twice daily for three weeks, followed by 20 mg daily. Anticoagulation will continue for three months regardless of the length of time the catheter is in place. Continuation of anticoagulation beyond this time period is at the discretion of the investigators.
Strengths of this study include its prospective cohort format, and access to a large oncologic population through the London Regional Cancer Program and other corresponding centres. In addition, The Catheter Study looking at CVC survival and safety in patients with cancer diagnosed with UEDVT and treated with a bridging protocol of warfarin/dalteparin was organized primarily through the LHSc and results therein could be directly compared to the results from this study given the similar patient population.
Limitations of this study include the small sample size and the fact that there is no LMWH monotherapy comparison group. In addition, this will be an open study with no blinding, given the nature of line survival. There is also the chance that a proportion of patients will have their catheters removed for other reasons, such as finishing treatment or personal preference, which could affect the validity of survival results.
This design was selected given the small number of patients presenting with this diagnosis each year at our centre, which would present difficulty in accruing enough patients for several comparisons group. Results will be compared to the Catheter Study and previous literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Other | Drug: RivaroxabanRivaroxaban 15 mg po bid x 3 weeks, followed by rivaroxaban 20 mg po daily x 9 weeks. Then up to discretion of investigator to decide regarding further anticoagulation as study length is limited to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female > 18 years of age.
- Symptomatic acute upper limb thrombosis in the axillary, subclavian, innominate or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or CT scan.
- Diagnosis of active malignancy (other than non-melanoma skin cancer), defined as patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
- Willing to provide written informed consent.
Key exclusion criteria (12 listed)
- Dialysis catheters.
- Active bleeding or high risk for major bleeding.
- Platelet Count < 75 x 109/L.
- Creatinine Clearance < 30 mL/min.
- Currently on other anticoagulant with therapeutic intent for another indication.*
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 |
|---|---|---|
| RivaroxabanAlso: XareltoAll specified in arm description. One arm study. | Drug | Rivaroxaban |
Primary outcome
Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA.
Time frame: 12 weeks
The primary endpoint of the study will be proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA, within the 3 months of study follow-up.
5 secondary outcomes
Recurrence of DVT or PE
Time frame: 12 weeks
Major Bleeding
Time frame: 12 weeks
Clinically Relevant Non-Major Bleeding
Time frame: 12 weeks
Death
Time frame: 12 weeks
Time to Central Line Failure
Time frame: 12 weeks
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 8 Sep 2016.
- Background: PubMed 17488349Kovacs MJ, Kahn SR, Rodger M, Anderson DR, Andreou R, Mangel JE, Morrow B, Clement AM, Wells PS. A pilot study of central venous catheter survival in cancer patients using low-molecular-weight heparin (dalteparin) and warfarin without catheter removal for the treatment of upper extremity deep vein thrombosis (The Catheter Study). J Thromb Haemost. 2007 Aug;5(8):1650-3. doi: 10.1111/j.1538-7836.2007.02613.x. Epub 2007 May 7.
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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.
Dr. Michael J. Kovacs, MD, FRCPC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban in people with Neoplasm and Central Venous Catheter Thrombosis, run by London Health Sciences Centre at 1 site in Canada.
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 4 inclusion and 12 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 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA. (time frame: 12 weeks). 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 NCT01708850, 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 8 Sep 2016.