Ischemic StrokePhase 2/3AA-ICASNCT05700266
Anticoagulation Using Rivaroxaban on Top of Aspirin in Intracranial Atherosclerotic Stenosis
A Phase 2/3 study testing Rivaroxaban, Clopidogrel and Aspirin in people with Ischemic Stroke and Intracranial Atherosclerosis, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Ischemic Stroke, Intracranial Atherosclerosis, Stenosis
- What is being tested?
- Rivaroxaban, Clopidogrel and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2023to Dec 2024
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years and ≤ 75 years
- TIA or Acute ischemic stroke that occurred within 30 days prior to randomization.
- Modified Rankin score of ≤ 3
- TIA or Acute ischemic stroke attributed to a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using magnetic resonance angiography (MRA), or computerized tomographic angiography (CTA), high resolution MR, or digital substraction angiography (DSA).
- To increase the likelihood that the symptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
- insulin dependent diabetes for at least 15 years. ii. at least 2 of the following atherosclerotic risk factors: hypertension (blood pressure ≥ 140/90 or on antihypertensive therapy); dyslipidemia (low density lipoprotein [LDL] ≥ 130 mg /dl or high density lipoprotein [HDL] < 40 mg/dl or fasting triglycerides ≥150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.
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- history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.
- any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic. v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography.
- any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.
- Patient agrees with follow-up visits and is available by phone.
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Who cannot join
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization)
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for any other cerebral blood vessels (common carotid artery [CCA], ICA, VA, MCA, anterior cerebral artery [ACA], posterior cerebral artery [PCA] et al)
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to randomization
- Progressive neurological signs within 24 hours prior to enrollment
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
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- Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebral spinal fluid pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
- Known allergy or contraindication to aspirin, clopidogrel or rivaroxaban.
- Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, international normalized ration [INR] > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (aspartate transaminase [AST] or alanine transaminase [ALT] > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis)
- Major surgery (including open femoral, aortic, cardiac or carotid surgery) within previous 30 days or planned in the next 1 year after enrollment.
- Any condition other than intracranial arterial stenosis that requires the subject to take any antithrombotic medication other than aspirin (NOTE: exceptions allowed for use of subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized)
- Severe neurological deficit that renders the patient incapable of living independently
- Dementia or psychiatric problem that prevents the patient from relevant evaluation or follow-up reliably
- Co-morbid conditions that may limit survival to less than 1 year
- Currently breastfeeding, pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
- Enrollment in another study that would conflict with the current study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anticoagulation Using Rivaroxaban on Top of Aspirin in Recent Stroke/Transient Ischemic Attack Patients With Intracranial Atherosclerotic Stenosis (AA-ICAS)
The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Participants will be divided into 2 groups to receive either oral rivaroxaban plus aspirin or oral clopidogrel plus aspirin. The main question it aims to answer is whether the experimental group (oral rivaroxaban plus aspirin) is superior to the control group ( oral clopidogrel plus aspirin) to lower recurrent stroke/TIA or death in these patients during 1 year of follow-up.
Read the detailed description
Intracranial atherosclerotic stenosis (ICAS) accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (dual antiplatelet therapy using asprin and clopidogrel, intensive management of vascular risk factors, and lifestyle modification) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group.
Rivaroxaban is a Non-vitamin K antagonist oral anticoagulant (NOAC) that Directly and selectively inhibits factor Xa. 2019 European Society of Cardiology (ESC) recommended that adding rivaroxaban (2.5mg twice a day) to aspirin for long-term secondary prevention in patients with chronic coronary syndromes (post-myocardial infarction >1 year) may be considered (IIB). 2020 ESC also recommended the adding of rivaroxaban (2.5mg twice a day for 1 year) to aspirin plus clopidogrel in acute coronary syndrome (IIB).
The proposed study will directly compare rivaroxaban on top of aspirin with clopidogrel on top of asprin for preventing recurrent stroke/TIA and death in recent stroke/TIA patients with ICAS.
The investigators calculated that a sample of 1180 patients (590 in each arm) would provide 80% power to detect a relative risk reduction of 35% in the ravaxaban-aspirin group, with a two-sided type I error of 0.05, assuming an event rate of 15% in the clopidogrel-aspirin group and a 5% overall rate of withdrawal.
Baseline features of the two groups were compared with the use of an independent group t-test (for means) or chi-square test (for percentages). Analysis of primary and secondary outcomes was based on Kaplan-Meier estimates of cumulative incidence. All analyses were performed on an intention-to-treat basis, unless specified otherwise. All tests were two-sided, and a P value of 0.05 was considered to indicate statistical significance. All statistical analyses were performed with the use of SPSS software.
- Conditions
- Ischemic Stroke, Intracranial Atherosclerosis, Stenosis
- Being tested
- Rivaroxaban, Clopidogrel, Aspirin, Risk Factor Management in both arms
- Keywords
- rivaroxaban, stroke, intracranial atherosclerosis stenosis
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis, Constriction, Pathologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban (2.5mg orally twice a day for 90 days)
ClopidogrelDrug
Clopidogrel (300mg loading dose, then 75mg once daily for 90 days)
AspirinDrug
Aspirin (100mg once a day for 1 year)
Risk Factor Management in both armsOther
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban and Aspirin | Experimental | Rivaroxaban (2.5mg orally twice a day for 90 days) and Aspirin (100mg once a day for 1 year) Receives: Drug: Rivaroxaban; Drug: Aspirin; Other: Risk Factor Management in both arms |
| Clopidogrel and Aspirin | Active comparator | Clopidogrel (300mg loading dose, then 75mg once daily for 90 days) and Aspirin (100mg once a day for 1 year) Receives: Drug: Clopidogrel; Drug: Aspirin; Other: Risk Factor Management in both arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up
Measured: the primary outcome will be assessed during 1 year of follow-up after recruitments.
Secondary outcomes (4)
Changes in the neurological function recovery
Neurological function will be evaluated using National Institute of Health stroke scale (NIHSS), modified Ranking Scale.
Measured: Neurological function will be evaluated at 90 days, 6 months and 1 year after recruitments.
Major non-intracranial bleeding
Major non-intracranial bleeding is defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria:
clinically overt bleeding with a fatal outcome, a reduction in haemoglobin level of ≥20 g/l within 7 days, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ (intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal).
Measured: during 1 year of follow-up after recruitments.
Clinically relevant non-major bleeding
Clinically relevant non-major bleeding is defined as bleeding not fulfilling the ISTH criteria, but that was clinically overt and led to hospitalization, change of antithrombotic therapy, or necessitated a medical or surgical intervention.
Measured: during 1 year of follow-up after recruitments.
acute myocardial infarction,acute limb ischemia
Measured: during 1 year of follow-up after recruitments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Dec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an investigator initiated, randomized, blinded endpoint assessment, clinical trial and conducted at 10 sites in the China. Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, Doctor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700266
- Sponsor's protocol ID
- AA-ICAS
- Acronym
- AA-ICAS
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be available to other researchers under reasonable request and approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Using Rivaroxaban on Top of Aspirin in Recent Stroke/Transient Ischemic Attack Patients With Intracranial Atherosclerotic Stenosis (AA-ICAS)
- ClinicalTrials.gov ID
- NCT05700266
- Acronym / sponsor ID
- AA-ICAS / AA-ICAS
- Conditions
- Ischemic Stroke, Intracranial Atherosclerosis, Stenosis
- Keywords
- rivaroxaban, stroke, intracranial atherosclerosis stenosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,180 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Participants will be divided into 2 groups to receive either oral rivaroxaban plus aspirin or oral clopidogrel plus aspirin. The main question it aims to answer is whether the experimental group (oral rivaroxaban plus aspirin) is superior to the control group ( oral clopidogrel plus aspirin) to lower recurrent stroke/TIA or death in these patients during 1 year of follow-up.
Detailed description
Intracranial atherosclerotic stenosis (ICAS) accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (dual antiplatelet therapy using asprin and clopidogrel, intensive management of vascular risk factors, and lifestyle modification) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group.
Rivaroxaban is a Non-vitamin K antagonist oral anticoagulant (NOAC) that Directly and selectively inhibits factor Xa. 2019 European Society of Cardiology (ESC) recommended that adding rivaroxaban (2.5mg twice a day) to aspirin for long-term secondary prevention in patients with chronic coronary syndromes (post-myocardial infarction >1 year) may be considered (IIB). 2020 ESC also recommended the adding of rivaroxaban (2.5mg twice a day for 1 year) to aspirin plus clopidogrel in acute coronary syndrome (IIB).
The proposed study will directly compare rivaroxaban on top of aspirin with clopidogrel on top of asprin for preventing recurrent stroke/TIA and death in recent stroke/TIA patients with ICAS.
The investigators calculated that a sample of 1180 patients (590 in each arm) would provide 80% power to detect a relative risk reduction of 35% in the ravaxaban-aspirin group, with a two-sided type I error of 0.05, assuming an event rate of 15% in the clopidogrel-aspirin group and a 5% overall rate of withdrawal.
Baseline features of the two groups were compared with the use of an independent group t-test (for means) or chi-square test (for percentages). Analysis of primary and secondary outcomes was based on Kaplan-Meier estimates of cumulative incidence. All analyses were performed on an intention-to-treat basis, unless specified otherwise. All tests were two-sided, and a P value of 0.05 was considered to indicate statistical significance. All statistical analyses were performed with the use of SPSS software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is an investigator initiated, randomized, blinded endpoint assessment, clinical trial and conducted at 10 sites in the China. Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year.
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban and Aspirin | Experimental | Drug: Rivaroxaban, Drug: Aspirin, Other: Risk Factor Management in both armsRivaroxaban (2.5mg orally twice a day for 90 days) and Aspirin (100mg once a day for 1 year) |
| Clopidogrel and Aspirin | Active comparator | Drug: Clopidogrel, Drug: Aspirin, Other: Risk Factor Management in both armsClopidogrel (300mg loading dose, then 75mg once daily for 90 days) and Aspirin (100mg once a day for 1 year) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 30 years and ≤ 75 years
- TIA or Acute ischemic stroke that occurred within 30 days prior to randomization.
- Modified Rankin score of ≤ 3
- TIA or Acute ischemic stroke attributed to a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using magnetic resonance angiography (MRA), or computerized tomographic angiography (CTA), high resolution MR, or digital substraction angiography (DSA).
- To increase the likelihood that the symptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
Key exclusion criteria (17 listed)
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization)
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for any other cerebral blood vessels (common carotid artery [CCA], ICA, VA, MCA, anterior cerebral artery [ACA], posterior cerebral artery [PCA] et al)
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to randomization
- Progressive neurological signs within 24 hours prior to enrollment
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 |
|---|---|---|
| RivaroxabanRivaroxaban (2.5mg orally twice a day for 90 days) | Drug | Rivaroxaban and Aspirin |
| ClopidogrelClopidogrel (300mg loading dose, then 75mg once daily for 90 days) | Drug | Clopidogrel and Aspirin |
| AspirinAspirin (100mg once a day for 1 year) | Drug | Clopidogrel and Aspirin, Rivaroxaban and Aspirin |
| Risk Factor Management in both armsRisk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed | Other | Clopidogrel and Aspirin, Rivaroxaban and Aspirin |
Primary outcome
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up
Time frame: the primary outcome will be assessed during 1 year of follow-up after recruitments.
4 secondary outcomes
Changes in the neurological function recovery
Time frame: Neurological function will be evaluated at 90 days, 6 months and 1 year after recruitments.
Major non-intracranial bleeding
Time frame: during 1 year of follow-up after recruitments.
Clinically relevant non-major bleeding
Time frame: during 1 year of follow-up after recruitments.
acute myocardial infarction,acute limb ischemia
Time frame: during 1 year of follow-up after recruitments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No. Individual participant data will be available to other researchers under reasonable request and approved by the ethics committee.
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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.
Kezhong Zhang, Doctor study chair
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rivaroxaban, Clopidogrel and Aspirin in people with Ischemic Stroke and Intracranial Atherosclerosis, run by The First Affiliated Hospital with Nanjing Medical University.
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 11 inclusion and 17 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhaolu Wang, Doctor (+86-18100613663, wangzhaolu123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up (time frame: the primary outcome will be assessed during 1 year of follow-up after recruitments.). 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 21 Dec 2023.