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Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

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ClinicalTrials.gov Identifier: NCT02689037
Recruitment Status : Not yet recruiting
First Posted : February 23, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Feng-Feng Shen, The 476th Hospital of People's Liberation Army

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Intracranial Atherosclerosis Procedure: Percutaneous transluminal angioplasty and stenting Drug: Aspirin plus clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: stenting+medical treatment
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Procedure: Percutaneous transluminal angioplasty and stenting
Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
Other Name: PTAS

Drug: Aspirin plus clopidogrel
aspirin 100mg daily and clopidogrel 75mg daily for 90 days
Other Name: Aspirin+clopidogrel

Active Comparator: Aspirin plus clopidogrel
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
Drug: Aspirin plus clopidogrel
aspirin 100mg daily and clopidogrel 75mg daily for 90 days
Other Name: Aspirin+clopidogrel




Primary Outcome Measures :
  1. Proportion of patients with events of stroke or death [ Time Frame: at 30 days after randomization ]

Secondary Outcome Measures :
  1. the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory [ Time Frame: 30 days and 1 year after randomization ]
  2. 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 ]
  3. Proportion of patients with adverse events [ Time Frame: 30 days and 1 year after randomization ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689037


Contacts
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Contact: Xiao-Ping Cui, MD 0591-22859529 xiaopingcuidr@126.com

Sponsors and Collaborators
The 476th Hospital of People's Liberation Army
Investigators
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Principal Investigator: Hang Lin, MD Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Feng-Feng Shen, Doctor, The 476th Hospital of People's Liberation Army
ClinicalTrials.gov Identifier: NCT02689037     History of Changes
Other Study ID Numbers: 12MA100
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists