Intracranial AtherosclerosisPhase 3NCT02689037
Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
A Phase 3 study testing Percutaneous transluminal angioplasty and stenting and Aspirin plus clopidogrel in people with Intracranial Atherosclerosis, run by The 476th Hospital of People's Liberation Army.
Trial summary
Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Atherosclerosis
- What is being tested?
- Percutaneous transluminal angioplasty and stenting and Aspirin plus clopidogrel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 70 years.
- Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
- A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
- Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
- CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
- Patients who understand the purpose of the study and have provided informed consent.
Who cannot join
- Not able to receive general anesthesia.
- Not able to receive angiographic assessment.
- A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
- Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
- A high risk (leading to a stroke or death) to deliver the stent to the lesion.
- A previous stent or angioplasty in the target lesion.
Show all 16Show fewer
- Progressive neurological signs within 24 hours before enrolment
- Any haemorrhagic infarct within 14 days before enrolment
- The presence of a cardiac source of embolus
- Thrombolytic therapy within 24 hours before enrollment
- Presence of intraluminal thrombus proximal to or at the target lesion
- Myocardial infarction within previous 30 days
- Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
- Known contraindications for aspirin and clopidogrel treatment.
- An modified Rankin scale≥3.
- With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.
Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.
Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.
- Conditions
- Intracranial Atherosclerosis
- Being tested
- Percutaneous transluminal angioplasty and stenting, Aspirin plus clopidogrel
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal angioplasty and stentingProcedure or surgery
Also called PTAS
Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
Aspirin plus clopidogrelDrug
Also called Aspirin+clopidogrel
aspirin 100mg daily and clopidogrel 75mg daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| stenting+medical treatment | Experimental | Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily) Receives: Procedure: Percutaneous transluminal angioplasty and stenting; Drug: Aspirin plus clopidogrel |
| Aspirin plus clopidogrel | Active comparator | Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days. Receives: Drug: Aspirin plus clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with events of stroke or death
Measured: at 30 days after randomization
Secondary outcomes (3)
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
Measured: 30 days and 1 year after randomization
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
Measured: 30 days and 1 year after randomization
Proportion of patients with adverse events
Measured: 30 days and 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (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 Intracranial AtherosclerosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 476th Hospital of People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Feng Shen, The 476th Hospital of People's Liberation Army
- Investigators
- Hang Lin, MD, Principal investigator, Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689037
- Sponsor's protocol ID
- 12MA100
- Status last verified
- Apr 2016
- First submitted
- 17 Feb 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cui XP, Lin M, Mu JS, Ye JX, He WQ, Fu ML, Li H, Fang JY, Shen FF, Lin H. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial. BMJ Open. 2016 Nov 15;6(11):e012175. doi: 10.1136/bmjopen-2016-012175.
PubMed 27852711
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02689037
- Acronym / sponsor ID
- 12MA100
- Conditions
- Intracranial Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- The 476th Hospital of People's Liberation ArmyUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Feb 2016 (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.
Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.
Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.
Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stenting+medical treatment | Experimental | Procedure: Percutaneous transluminal angioplasty and stenting, Drug: Aspirin plus clopidogrelPatients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily) |
| Aspirin plus clopidogrel | Active comparator | Drug: Aspirin plus clopidogrelPatients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged from 18 to 70 years.
- Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
- A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
- Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
- CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
Key exclusion criteria (16 listed)
- Not able to receive general anesthesia.
- Not able to receive angiographic assessment.
- A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
- Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
- A high risk (leading to a stroke or death) to deliver the stent to the lesion.
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 |
|---|---|---|
| Percutaneous transluminal angioplasty and stentingAlso: PTASSurgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization. | Procedure or surgery | stenting+medical treatment |
| Aspirin plus clopidogrelAlso: Aspirin+clopidogrelaspirin 100mg daily and clopidogrel 75mg daily for 90 days | Drug | Aspirin plus clopidogrel, stenting+medical treatment |
Primary outcome
Proportion of patients with events of stroke or death
Time frame: at 30 days after randomization
3 secondary outcomes
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
Time frame: 30 days and 1 year after randomization
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
Time frame: 30 days and 1 year after randomization
Proportion of patients with adverse events
Time frame: 30 days and 1 year after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Derived from this study: PubMed 27852711Cui XP, Lin M, Mu JS, Ye JX, He WQ, Fu ML, Li H, Fang JY, Shen FF, Lin H. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial. BMJ Open. 2016 Nov 15;6(11):e012175. doi: 10.1136/bmjopen-2016-012175.
- Individual participant dataSharing planned: Undecided
Related trials for Intracranial Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Not yet recruiting
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
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.
Hang Lin, MD principal investigator
Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous transluminal angioplasty and stenting and Aspirin plus clopidogrel in people with Intracranial Atherosclerosis, run by The 476th Hospital of People's Liberation Army.
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 6 inclusion and 16 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 5 Apr 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Ping Cui, MD (0591-22859529, xiaopingcuidr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with events of stroke or death (time frame: at 30 days after randomization). 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 NCT02689037, 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 5 Apr 2016.