Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)Phase 2/3ENCHASENCT03570281
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
A Phase 2/3 study testing Edoxaban and Enoxaparin in people with Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
- What is being tested?
- Edoxaban and Enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2018to 30 Nov 2020
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 20 years old
- Acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (DWI)
- Cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer.
- with informed consent from the patient or next-of-kin, When the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject.
Who cannot join
- Patients with primary intracranial malignancy
- Patients with classic causes of cerebral infarction
- Patients with infectious or immunological disease that may affect blood D-dimer levels
- Patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue)
- Patients who can not use anticoagulants with thrombocytopenia (platelet <50,000), anemia (hemoglobin <8)
- Decreased renal function (creatine clearance <15 mL / mim)
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- Patients who received intravenous tissue plasminogen activator
- Patients with uncontrolled severe hypertension
- Patients who received prosthetic heart valve replacement requiring anticoagulation
- Patients with moderate to severe mitral stenosis
- Pulmonary embolism requiring hemodynamically unstable or thrombolysis or pulmonary embolization
- Pregnant and lactating women
- Patients who are hypersensitive to the major component or constituent of the test drug
- Patients with liver diseases associated with blood clotting disorders and clinically significant bleeding risks
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology, Samsung Medical Center
Seoul, 135-710
Oh Young Bang, MD PhD, 82-2-3410-3599, neuroboy50@naver.com
Jong-Won Chung, MD MSc, 82-2-3410-3599, neurocjw@gmail.com
About this study
Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.
- Being tested
- Edoxaban, Enoxaparin
- Keywords
- cancer-related stroke, coagulopathy, D-dimer, Edoxaban, enoxaparine
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days.
EnoxaparinDrug
Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban group | Experimental | Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days. Receives: Drug: Edoxaban |
| Enoxaparin group | Active comparator | Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days. Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-dimer change
interval change of serum D-dimer level between day 0 and 7
Measured: 7 days after treatment
Secondary outcomes (3)
Surrogate endpoint
number of micro-embolic signal detected by transcranial doppler
Measured: 7 days after treatment
Functional outcome
modified Rankin scale at 90 days, from 0 to 6, higher is worse
Measured: 90 days after enrollment
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
symptomatic intracerebral hemorrhage major bleeding all-cause death
Measured: 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Jun 2018
- Primary completion31 May 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
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 Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oh Young Bang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570281
- Sponsor's protocol ID
- SMC 2017-11-163-007
- Acronym
- ENCHASE
- Status last verified
- Jun 2018
- First submitted
- 14 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chung JW, Hwang J, Kim HJ, Seo WK, Ahn MJ, Saver JL, Bang OY. Edoxaban for the treatment of hypercoagulability and cerebral thromboembolism associated with cancer: A randomized clinical trial of biomarker targets. Int J Stroke. 2024 Jul;19(6):645-653. doi: 10.1177/17474930241239266. Epub 2024 Mar 21.
PubMed 38429253
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
- ClinicalTrials.gov ID
- NCT03570281
- Acronym / sponsor ID
- ENCHASE / SMC 2017-11-163-007
- Keywords
- cancer-related stroke, coagulopathy, D-dimer, Edoxaban, enoxaparine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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.
Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban group | Experimental | Drug: EdoxabanEdoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days. |
| Enoxaparin group | Active comparator | Drug: EnoxaparinEnoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 20 years old
- Acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (DWI)
- Cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer.
- with informed consent from the patient or next-of-kin, When the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject.
Key exclusion criteria (14 listed)
- Patients with primary intracranial malignancy
- Patients with classic causes of cerebral infarction
- Patients with infectious or immunological disease that may affect blood D-dimer levels
- Patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue)
- Patients who can not use anticoagulants with thrombocytopenia (platelet <50,000), anemia (hemoglobin <8)
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 |
|---|---|---|
| EdoxabanEdoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days. | Drug | Edoxaban group |
| EnoxaparinEnoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days. | Drug | Enoxaparin group |
Primary outcome
D-dimer change
Time frame: 7 days after treatment
interval change of serum D-dimer level between day 0 and 7
3 secondary outcomes
Surrogate endpoint
Time frame: 7 days after treatment
Functional outcome
Time frame: 90 days after enrollment
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
Time frame: 90 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 38429253Chung JW, Hwang J, Kim HJ, Seo WK, Ahn MJ, Saver JL, Bang OY. Edoxaban for the treatment of hypercoagulability and cerebral thromboembolism associated with cancer: A randomized clinical trial of biomarker targets. Int J Stroke. 2024 Jul;19(6):645-653. doi: 10.1177/17474930241239266. Epub 2024 Mar 21.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Edoxaban and Enoxaparin in people with Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban), run by Samsung Medical Center at 1 site in South Korea.
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 14 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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 South Korea. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-dimer change (time frame: 7 days after treatment). 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 NCT03570281, 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 26 Jun 2018.