Venous ThromboembolismPhase 3NCT02583191
Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
A Phase 3 study testing Rivaroxaban and low-molecular heparine in people with Venous Thromboembolism and Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer
- What is being tested?
- Rivaroxaban and low-molecular heparine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2016to 19 Aug 2019
- 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
- Newly diagnosed and objectively confirmed acute venous thromboembolism
- Active malignancy
- Life expectancy of at least 6 months
- Performance-Status according to Karnofsky Performance Scale ≥ 70 %
- Patient's compliance and geographical situation allowing an adequate follow up
- platelets ≥ 100.000 /μl, INR < 1.5, PTT < 40 sec.
- written informed consent of the patient prior to any procedure in connection with the study
- male and female patients with an age of at least 18 years
Who cannot join
- therapeutic anticoagulation > 96 hours prior to study treatment
- known allergic reactions against the study drugs or the substances included therein
- known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
- acute clinically relevant bleeding in the last 2 weeks
- any history of spontaneous major/cerebral bleeding
- history of heparin induced thrombocytopenia II
Show all 12Show fewer
- pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed < 7 days prior to start of the treatment
- severe renal insufficiency (GFR < 30 ml/min)
- liver disease with coagulation impairment, including Child B and C
- cirrhosis
- acute medical illness
- treatment of the underlying cancer with experimental therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH).
Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.
- Conditions
- Venous Thromboembolism, Cancer
- Being tested
- Rivaroxaban, low-molecular heparine
- Medical subject headings
- Venous Thromboembolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
low-molecular heparineDrug
LMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g.
- Enoxaparin 1 mg/kg BW twice daily
- Tinzaparin 175 I.E./kg BW once daily
- Dalteparin 200 I.E./kg BW once daily
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Arm A: Rivaroxaban Receives: Drug: Rivaroxaban |
| low-molecular heparine | Active comparator | Arm B: standard treatment with low-molecular heparine Receives: Drug: low-molecular heparine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin
Measured: From randomization to 4 weeks after treatment start
Secondary outcomes (9)
Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment
Measured: From randomization to 3 months after treatment start
Exploratory analysis for "time on treatment"
Measured: From randomization to 12 weeks after treatment start
Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics
Measured: From randomization to end of follow up (up to 24 weeks)
Rate of myocardial infarction and ischemic stroke
Measured: From randomization to end of follow up (up to 24 weeks)
Compliance of patients (adherence)
Measured: From randomization to end of follow up (up to 24 weeks)
Overall mortality 3 and 6 months after randomization
Measured: From randomization to 3 and 6 months after randomization
Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM
Measured: 4 weekly, up to 12 weeks
Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months
Measured: From randomization to 3 months after randomization
Rate of minor bleedings within 3 months
Measured: From randomization to 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start23 Mar 2016
- Primary completion11 Jun 2019
- Study completion19 Aug 2019
Why it stopped: Recruitment was not as expected.
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 Venous ThromboembolismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583191
- Sponsor's protocol ID
- CONKO-011 AIO-SUP-0115/ass.
- Status last verified
- Apr 2021
- First submitted
- 15 Oct 2015
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.
PubMed 34172290
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT02583191
- Acronym / sponsor ID
- CONKO-011 AIO-SUP-0115/ass.
- Conditions
- Venous Thromboembolism, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was not as expected.
- Enrolment
- 246 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Bayer
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 22 Oct 2015 (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.
The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH).
Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanArm A: Rivaroxaban |
| low-molecular heparine | Active comparator | Drug: low-molecular heparineArm B: standard treatment with low-molecular heparine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed and objectively confirmed acute venous thromboembolism
- Active malignancy
- Life expectancy of at least 6 months
- Performance-Status according to Karnofsky Performance Scale ≥ 70 %
- Patient's compliance and geographical situation allowing an adequate follow up
Key exclusion criteria (12 listed)
- therapeutic anticoagulation > 96 hours prior to study treatment
- known allergic reactions against the study drugs or the substances included therein
- known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
- acute clinically relevant bleeding in the last 2 weeks
- any history of spontaneous major/cerebral bleeding
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: XareltoRivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months | Drug | Rivaroxaban |
| low-molecular heparineLMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g. * Enoxaparin 1 mg/kg BW twice daily * Tinzaparin 175 I.E./kg BW once daily * Dalteparin 200 I.E./kg BW once daily | Drug | low-molecular heparine |
Primary outcome
Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin
Time frame: From randomization to 4 weeks after treatment start
9 secondary outcomes
Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment
Time frame: From randomization to 3 months after treatment start
Exploratory analysis for "time on treatment"
Time frame: From randomization to 12 weeks after treatment start
Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics
Time frame: From randomization to end of follow up (up to 24 weeks)
Rate of myocardial infarction and ischemic stroke
Time frame: From randomization to end of follow up (up to 24 weeks)
Compliance of patients (adherence)
Time frame: From randomization to end of follow up (up to 24 weeks)
Overall mortality 3 and 6 months after randomization
Time frame: From randomization to 3 and 6 months after randomization
Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM
Time frame: 4 weekly, up to 12 weeks
Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months
Time frame: From randomization to 3 months after randomization
Rate of minor bleedings within 3 months
Time frame: From randomization to 3 months after randomization
Results and safety
The study was stopped early (reason given: Recruitment was not as expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 34172290Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban and low-molecular heparine in people with Venous Thromboembolism and Cancer, run by AIO-Studien-gGmbH at 1 site in Germany.
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 8 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: stopped early, as of the sponsor's last update on 3 May 2021. 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 Germany. 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 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 was stopped early (reason given: Recruitment was not as expected.). Results are not available in the source record.
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?
Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin (time frame: From randomization to 4 weeks after treatment start). 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 NCT02583191, 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 3 May 2021.