Ischemic StrokePhase 4NCT03871517
INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
A Phase 4 study testing Indobufen and Aspirin in people with Ischemic Stroke and Indobufen, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Indobufen, Aspirin
- What is being tested?
- Indobufen and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,438 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 1 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged≥18 years and<80years.
- Acute moderate/severe ischemic stroke, 4≤NIHSS（National Institute of Health stroke scale）≤18 at the time of randomization.
- Patients can be randomized within 72 hours of symptoms onset.
- Provision of informed consent prior to any study specific procedures. * Symptom onset is defined by the "last seen normal" principle
Who cannot join
- Diagnosis of intracerebral hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, etc.
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Moderate to severe ischemic stroke induced by angioplasty/vascular surgery.
- Modified Rankin Scale Score>2 at randomization (pre-morbid historical assessment).
- History of aneurysm (including intracranial aneurysm or peripheral aneurysms).
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, atrial myxoma, prosthetic cardiac valves known or suspected endocarditis).
Show all 24Show fewer
- History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia.
- History of previous symptomatic non-traumatic intracerebral bleed or cerebral artery amyloidosis.
- Gastrointestinal (GI) bleed within the past 6 months before randomization.
- Major surgery within the past 3 months before randomization.
- Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value>3 times normal upper limit or Aspartate aminotransferase (AST)>2 times normal upper limit; Severe renal insufficiency is defined as creatinine>2 times normal upper limit).
- Diagnosis or of acute coronary syndrome.
- Other antithrombotic therapy are required during the study, including antiplatelet therapy(such as open-labeled aspirin, GPIIb/IIIa inhibitors, clopidogrel, ticagrelor, prasugrel, dipyridamole, ozagrel, cilostazol, etc.) and anticoagulant therapy(such as warfarin, thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, heparin and low molecular heparin, etc.).
- Within randomized 24 hours prior to any venous or arterial thrombolysis, mechanical bolt, snake venom, defibrase, lumbrokinase, etc.
- Heparin or oral anticoagulants were used within 10 days of randomization.
- Have a history of drug or food allergy and are known to be allergic to the study drug ingredients
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
- Anticipated requirement for long-term (>7 days) non-steroidal antiinflammatory drugs (NSAIDs).
- The blood pressure needs to be controlled within the range of 90mmHg/60mmHg to 220mmHg/120mmHg.
- Suffering from serious cardiopulmonary disease, the researchers believe that it is not suitable for this study
- Patients with life expectancy<3 months or patients who are unable to complete the study for other reasons.
- Women of childbearing age who are negative in pregnancy test but refuse to practice reliable contraception. Women who are pregnant or lactating.
- Involving in other investigational drug or device tests within the past 30 days before randomization.
- Inability of the patient to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
Read the detailed description
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy. The study is a multicenter, randomized, double-blind, positive drug parallel control and non-inferiority clinical design.
Non-inferiority analysis was performed on the primary efficacy analysis, and both intent analysis (ITT) and compliance program set (PPS) were used for analysis. If the indobufen group was confirmed to be non-inferior to aspirin (control group), a superiority analysis was further performed to analyze whether the indobufen was superior to aspirin. At the same time, Kaplan-Meier curves were used to simulate the cumulative risk of stroke (ischemic or hemorrhagic) at 90-day follow-up, and the Cox proportional hazards model was used to calculate the hazard ratio (HR) and 95% confidence interval, Log-rank test was used to evaluate the treatment effect. All statistics will be two-sided with p<0.05 considered significant.
All patients who received study drugs and with at least one safety follow-up record will be included in the safety population. The data for safety evaluation included adverse reactions observed during the trial and changes in laboratory data before and after treatment.
- Conditions
- Ischemic Stroke, Indobufen, Aspirin
- Being tested
- Indobufen, Aspirin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndobufenDrug
Indobufen inhibits platelet aggregation by reversibly inhibiting the platelet cyclooxygenase enzyme thereby suppressing thromboxane synthesis.
AspirinDrug
Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Indobufen | Experimental | Drug: Indobufen and aspirin mimetic Day 1 to 90±7: The first time : Indobufen 100mg + aspirin mimetic The second time: indobufen 100mg Receives: Drug: Indobufen |
| Aspirin | Active comparator | Drug: Aspirin and Indobufen mimetic Day 1 to 90±7: The first time : aspirin 100mg+ Indobufen mimetic, The second time: indobufen mimetic. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any new stroke event (ischemic stroke or hemorrhagic stroke)
To evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
Measured: 3 months after randomization
Severe or moderate bleeding
GUSTO definition
Measured: 3 months after randomization
Secondary outcomes (11)
Any new stroke event
ischemic stroke or hemorrhagic stroke
Measured: 1 year after randomization
New vascular events
ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death
Measured: 1 year after randomization
New ischemic stroke events
New ischemic stroke events
Measured: within 3 months and 1 year after randomization
modified Rankin Scale (mRS) score was compared between 0-2 and 3-6 in the two groups.
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials. The scale runs from 0-6, running from perfect health without symptoms to death: 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.
Measured: During the 3-month and 1-year follow-up
The proportion of mRS scores between 3 to 6 points
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials. The scale runs from 0-6, running from perfect health without symptoms to death: 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.
Measured: 3 months and 1 year
Changes in neurological impairment
changes in National Institutes of Health Stroke Scale (NIHSS) score at 3 months compared to baseline. The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. Stroke severity: 0 No stroke symptoms;1-4 Minor stroke;5-15 Moderate stroke;16-20 Moderate to severe stroke;21-42 Severe stroke
Measured: 3 months after randomization
Quality of life at 3 months and 1 year follow-up
We will use the EQ-5D-5L scale to evaluate the quality of life. EQ-5D-5L is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare. The EQ-5D-5L has five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain.
Measured: 3 months and 1 year after randomization
The proportion of early lower extremity venous thrombosis.
The proportion of early lower extremity venous thrombosis.
Measured: 3 months after randomization
All bleeding events
all bleeding: including severe or moderate hemorrhage, intracranial hemorrhage
Measured: 3 months after randomization
death
death
Measured: 3 months after randomization
Adverse events or serious adverse events
such as gastrointestinal reaction, gastrointestinal bleeding and renal impairment
Measured: 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 posted12 Mar 2019
- Study start3 Jun 2019
- Primary completion1 Mar 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871517
- Sponsor's protocol ID
- KY 2018-075-02
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2019
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan Y, Meng X, Yuan B, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Jiang Y, Xie X, Jin A, Suo Y, Yang H, Feng Y, Zhou Y, Liu Q, Li X, Liu B, Zhu H, Zhao J, Huang X, Li H, Xiong Y, Li Z, Wang Y, Zhao X, Liu L, Wang Y; INSURE Investigators. Indobufen versus aspirin in patients with acute ischaemic stroke in China (INSURE): a randomised, double-blind, double-dummy, active control, non-inferiority trial. Lancet Neurol. 2023 Jun;22(6):485-493. doi: 10.1016/S1474-4422(23)00113-8. Epub 2023 Apr 27.
PubMed 37121237Pan Y, Meng X, Chen W, Jing J, Lin J, Jiang Y, Johnston SC, Bath PM, Dong Q, Xu AD, Li H, Wang Y. Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial. Stroke Vasc Neurol. 2022 Oct;7(5):457-461. doi: 10.1136/svn-2021-001480. Epub 2022 Apr 7.
PubMed 35393360
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
- ClinicalTrials.gov ID
- NCT03871517
- Acronym / sponsor ID
- KY 2018-075-02
- Conditions
- Ischemic Stroke, Indobufen, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,438 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Mar 2019 (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.
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
Detailed description
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy. The study is a multicenter, randomized, double-blind, positive drug parallel control and non-inferiority clinical design.
Non-inferiority analysis was performed on the primary efficacy analysis, and both intent analysis (ITT) and compliance program set (PPS) were used for analysis. If the indobufen group was confirmed to be non-inferior to aspirin (control group), a superiority analysis was further performed to analyze whether the indobufen was superior to aspirin. At the same time, Kaplan-Meier curves were used to simulate the cumulative risk of stroke (ischemic or hemorrhagic) at 90-day follow-up, and the Cox proportional hazards model was used to calculate the hazard ratio (HR) and 95% confidence interval, Log-rank test was used to evaluate the treatment effect. All statistics will be two-sided with p<0.05 considered significant.
All patients who received study drugs and with at least one safety follow-up record will be included in the safety population. The data for safety evaluation included adverse reactions observed during the trial and changes in laboratory data before and after treatment.
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 |
|---|---|---|
| Indobufen | Experimental | Drug: IndobufenDrug: Indobufen and aspirin mimetic Day 1 to 90±7: The first time : Indobufen 100mg + aspirin mimetic The second time: indobufen 100mg |
| Aspirin | Active comparator | Drug: AspirinDrug: Aspirin and Indobufen mimetic Day 1 to 90±7: The first time : aspirin 100mg+ Indobufen mimetic, The second time: indobufen mimetic. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male aged≥18 years and<80years.
- Acute moderate/severe ischemic stroke, 4≤NIHSS（National Institute of Health stroke scale）≤18 at the time of randomization.
- Patients can be randomized within 72 hours of symptoms onset.
- Provision of informed consent prior to any study specific procedures. * Symptom onset is defined by the "last seen normal" principle
Key exclusion criteria (24 listed)
- Diagnosis of intracerebral hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, etc.
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Moderate to severe ischemic stroke induced by angioplasty/vascular surgery.
- Modified Rankin Scale Score>2 at randomization (pre-morbid historical assessment).
- History of aneurysm (including intracranial aneurysm or peripheral aneurysms).
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 |
|---|---|---|
| IndobufenIndobufen inhibits platelet aggregation by reversibly inhibiting the platelet cyclooxygenase enzyme thereby suppressing thromboxane synthesis. | Drug | Indobufen |
| AspirinAspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation. | Drug | Aspirin |
Primary outcome
Any new stroke event (ischemic stroke or hemorrhagic stroke)
Time frame: 3 months after randomization
To evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
Severe or moderate bleeding
Time frame: 3 months after randomization
GUSTO definition
11 secondary outcomes
Any new stroke event
Time frame: 1 year after randomization
New vascular events
Time frame: 1 year after randomization
New ischemic stroke events
Time frame: within 3 months and 1 year after randomization
modified Rankin Scale (mRS) score was compared between 0-2 and 3-6 in the two groups.
Time frame: During the 3-month and 1-year follow-up
The proportion of mRS scores between 3 to 6 points
Time frame: 3 months and 1 year
Changes in neurological impairment
Time frame: 3 months after randomization
Quality of life at 3 months and 1 year follow-up
Time frame: 3 months and 1 year after randomization
The proportion of early lower extremity venous thrombosis.
Time frame: 3 months after randomization
All bleeding events
Time frame: 3 months after randomization
death
Time frame: 3 months after randomization
Adverse events or serious adverse events
Time frame: 3 months after randomization
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 9 Jan 2023.
- Derived from this study: PubMed 37121237Pan Y, Meng X, Yuan B, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Jiang Y, Xie X, Jin A, Suo Y, Yang H, Feng Y, Zhou Y, Liu Q, Li X, Liu B, Zhu H, Zhao J, Huang X, Li H, Xiong Y, Li Z, Wang Y, Zhao X, Liu L, Wang Y; INSURE Investigators. Indobufen versus aspirin in patients with acute ischaemic stroke in China (INSURE): a randomised, double-blind, double-dummy, active control, non-inferiority trial. Lancet Neurol. 2023 Jun;22(6):485-493. doi: 10.1016/S1474-4422(23)00113-8. Epub 2023 Apr 27.
- Derived from this study: PubMed 35393360Pan Y, Meng X, Chen W, Jing J, Lin J, Jiang Y, Johnston SC, Bath PM, Dong Q, Xu AD, Li H, Wang Y. Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial. Stroke Vasc Neurol. 2022 Oct;7(5):457-461. doi: 10.1136/svn-2021-001480. Epub 2022 Apr 7.
- Individual participant dataSharing planned: No
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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 4 study testing Indobufen and Aspirin in people with Ischemic Stroke and Indobufen, run by Beijing Tiantan 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 4 inclusion and 24 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 9 Jan 2023. 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.
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?
Any new stroke event (ischemic stroke or hemorrhagic stroke) (time frame: 3 months after randomization). 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 NCT03871517, which also lists 2 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 9 Jan 2023.