VTE After StrokeNCT04726007
Management of TA in VaS-Patients and HT
An observational study of VTE After Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
Stroke is an independent risk factor for venous thrombosis (VTE), which leads to a significant increase in the mortality and disability rate after stroke. For patients with high risk factors for VTE such as advanced age, paralysis, infection, dehydration, etc., the incidence of death and disability is higher. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- VTE After Stroke
- What is being tested?
- Antithrombotic Agents
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We integrated pooled individual patient data of consecutive VaS patients treated at a single center (Departments of Neurology) in China from 1 January 2008 until 31 December 2020.
Who may be able to join
- Patients diagnosed with VTE after stroke
- Use at least one antithrombotic drug
Who cannot join
- Case information is incomplete
- Non-spontaneous cerebral hemorrhage
- Suffer from serious blood system disease
- Do not accept follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710000
About this study
Official title: Management of Therapeutic Antithrombotic in Patients With VTE After Stroke and Hemorrhagic Tendency
Stroke is an independent risk factor for venous thrombosis (VTE), which leads to a significant increase in the mortality and disability rate after stroke. For patients with high risk factors for VTE such as advanced age, paralysis, infection, dehydration, etc., the incidence of death and disability is higher. Studies have shown that the incidence of deep vein thrombosis in bedridden ischemic stroke patients is about 20%, and the incidence of pulmonary embolism is about 2%, and causes 10% of post-stroke deaths. In order to prevent the occurrence of VTE, the American Heart Association, the American Stroke Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, etc. pointed out in the guidelines that heparin or low molecular weight heparin should be used for stroke patients with "restricted mobility" or "incapable mobility" to prevent VTE. For patients with evidence of thrombosis or symptoms of DVT, antithrombotic therapy should be initiated immediately. Paradoxically, ischemic stroke significantly increases the risk of cerebral hemorrhage. Besides There is an increased risk of primary intracerebral hemorrhage (ICH) associated with aspirin or antiplatelet agent monotherapy and it is difficult to achieve a balance between preventing blood clots and reducing the risk of bleeding complications. In addition, stroke patients are elderly and have speech and intellectual impairment, and the non-specific symptoms and signs of intracranial hemorrhage caused by improper antithrombotic therapy make the rate of misdiagnosis and missed diagnosis extremely high. Therefore, clarifying the clinical characteristics of stroke patients with VTE and launching targeted interventions to effectively balance the risk of anti-thrombosis and bleeding have become the key to improving the prognosis of patients.
This study is based on real-world data to study the bleeding risk and antithrombotic treatment options in VaS (1) the risk factors associated with hemorrhage in patients with VTE after stroke; and (2) the characteristics and pharmacotherapeutics regimen of high-risk populations with VTE after stroke; and(3) the Optimal antithrombotic treatment regimen for patients with VTE after stroke, including the timing of starting and stopping the antithrombotic treatment, selection of varieties, dosage, and course of treatment, etc.
- Conditions
- VTE After Stroke
- Being tested
- Antithrombotic Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombotic AgentsDrug
Antithrombotic agents include anticoagulants, antiplatelet drugs, thrombolytic drugs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications during hospital stay in patients with VTE after stroke
Bleeding is defined as intracranial hemorrhage and non-intracranial hemorrhage, and thrombosis is defined as aggravated or new thrombosis.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jan 2018
- Primary completionFeb 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VTE After StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingwen Wang, Study director, The First Affiliated Hospital of the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726007
- Sponsor's protocol ID
- Wang JingWen-1
- Status last verified
- Dec 2020
- First submitted
- 20 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Therapeutic Antithrombotic in Patients With VTE After Stroke and Hemorrhagic Tendency
- ClinicalTrials.gov ID
- NCT04726007
- Acronym / sponsor ID
- Wang JingWen-1
- Conditions
- VTE After Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jan 2021 (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.
Stroke is an independent risk factor for venous thrombosis (VTE), which leads to a significant increase in the mortality and disability rate after stroke. For patients with high risk factors for VTE such as advanced age, paralysis, infection, dehydration, etc., the incidence of death and disability is higher. Studies have shown that the incidence of deep vein thrombosis in bedridden ischemic stroke patients is about 20%, and the incidence of pulmonary embolism is about 2%, and causes 10% of post-stroke deaths. In order to prevent the occurrence of VTE, the American Heart Association, the American Stroke Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, etc. pointed out in the guidelines that heparin or low molecular weight heparin should be used for stroke patients with "restricted mobility" or "incapable mobility" to prevent VTE. For patients with evidence of thrombosis or symptoms of DVT, antithrombotic therapy should be initiated immediately. Paradoxically, ischemic stroke significantly increases the risk of cerebral hemorrhage. Besides There is an increased risk of primary intracerebral hemorrhage (ICH) associated with aspirin or antiplatelet agent monotherapy and it is difficult to achieve a balance between preventing blood clots and reducing the risk of bleeding complications. In addition, stroke patients are elderly and have speech and intellectual impairment, and the non-specific symptoms and signs of intracranial hemorrhage caused by improper antithrombotic therapy make the rate of misdiagnosis and missed diagnosis extremely high. Therefore, clarifying the clinical characteristics of stroke patients with VTE and launching targeted interventions to effectively balance the risk of anti-thrombosis and bleeding have become the key to improving the prognosis of patients.
This study is based on real-world data to study the bleeding risk and antithrombotic treatment options in VaS (1) the risk factors associated with hemorrhage in patients with VTE after stroke; and (2) the characteristics and pharmacotherapeutics regimen of high-risk populations with VTE after stroke; and(3) the Optimal antithrombotic treatment regimen for patients with VTE after stroke, including the timing of starting and stopping the antithrombotic treatment, selection of varieties, dosage, and course of treatment, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We integrated pooled individual patient data of consecutive VaS patients treated at a single center (Departments of Neurology) in China from 1 January 2008 until 31 December 2020.
Key inclusion criteria (2 listed)
- Patients diagnosed with VTE after stroke
- Use at least one antithrombotic drug
Key exclusion criteria (4 listed)
- Case information is incomplete
- Non-spontaneous cerebral hemorrhage
- Suffer from serious blood system disease
- Do not accept follow-up
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 |
|---|---|---|
| Antithrombotic AgentsAntithrombotic agents include anticoagulants, antiplatelet drugs, thrombolytic drugs. | Drug | – |
Primary outcome
Complications during hospital stay in patients with VTE after stroke
Time frame: Through study completion, an average of 2 weeks.
Bleeding is defined as intracranial hemorrhage and non-intracranial hemorrhage, and thrombosis is defined as aggravated or new thrombosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Yes
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.
Jingwen Wang study director
The First Affiliated Hospital of the Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VTE After Stroke, run by Xijing Hospital at 1 site in China.
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 2 inclusion and 4 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 27 Jan 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 China. 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.
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?
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?
Complications during hospital stay in patients with VTE after stroke (time frame: Through study completion, an average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.