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Trial record 67 of 624 for:    ASPIRIN AND clopidogrel

Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689037
Recruitment Status : Unknown
Verified April 2016 by Feng-Feng Shen, The 476th Hospital of People's Liberation Army.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE February 23, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
Proportion of patients with events of stroke or death [ Time Frame: at 30 days after randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
Proportion of patients with events of stroke or death [ Time Frame: within 30 days after initiation of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
  • the rate of successful recanalisation (stenosis<50%) [ Time Frame: instantly after the procedure ]
  • the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory [ Time Frame: 30 days and 1 year postoperatively ]
  • neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS) [ Time Frame: 30 days and 1 year postoperatively ]
  • Proportion of patients with adverse events [ Time Frame: 30 days and 1 year postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
Official Title  ICMJE Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Atherosclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Procedure: Percutaneous transluminal angioplasty and stenting
    • Drug: Aspirin plus clopidogrel
  • Active Comparator: Aspirin plus clopidogrel
    Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
    Intervention: Drug: Aspirin plus clopidogrel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 27, 2016)
394
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2016)
198
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02689037
Other Study ID Numbers  ICMJE 12MA100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Feng-Feng Shen, The 476th Hospital of People's Liberation Army
Study Sponsor  ICMJE The 476th Hospital of People's Liberation Army
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hang Lin, MD Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University
PRS Account The 476th Hospital of People's Liberation Army
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP