Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting (APORIAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01255852
First received: December 3, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

Severe intracranial atherosclerosis with concomitant stenosis is responsible for approximately 10% of all strokes. Retrospective studies have indicated that up to 50% of patients with a recently symptomatic intracranial stenosis experience recurrent ischemic events. Due to the high stroke risk, patients with high grade 70% symptomatic intracranial stenosis represent the main target group for endovascular treatment. Atorvastatin is widely used in the treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose atorvastatin has been known to stop the progression of atherosclerosis and to decrease the levels of inflammatory markers. Several recent clinical trials have proved atorvastatin can reduce restenosis after stent implantation in coronary artery. But the feasibility of atorvastatin in preventing restenosis in patients with intracranial stenting has not been evaluated.The purpose of this prospective, randomized, single-blinded trial is to evaluate the effect of atorvastatin 80 mg daily in preventing restenosis and related vascular events in patients with intracranial stent implantation.


Condition Intervention Phase
CVD
Drug: atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 of Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Target lesion failure [ Time Frame: at two year ] [ Designated as safety issue: Yes ]
    Target lesion failure (TLF) will be conducted in-hospital and planned at 30 days, 3 months, 6 months, and 12 months. In-stent late diameter loss and stent patency will be evaluated by DSA (digital subtraction angiography) 12 months after the index procedure.


Secondary Outcome Measures:
  • Clinical endpoint [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
    Clinical endpoint measurements, TIA, minor stroke, ipsilateral stroke, major stroke, myocardial infarction, cardiovascular death and death, will be conducted in-hospital and planned at 30 days, 3 months, 6 months, and 12 months.

  • Angiographic follow-up [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
    Angiographic follow-up is planned at 3 and 9 months after the index procedure with TCD or CTA for evaluating in-stent blood flow velocity and stent patency.

  • In-segment binary restenosis rate 12 months after the index procedure [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
    In-segment binary restenosis rate 12 months after the index procedure will be evaluated with DSA.

  • Effects of atorvastatin on blood lipid and inflammatory levels [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
    Effects of atorvastatin on blood lipid and inflammatory levels will be evaluated by testing serum CRP, LDL, HDL and MMP-9 at baseline and at 12 month after the index procedure.

  • Effects of atorvastatin treatment on neurological function outcomes [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
    Effects of atorvastatin treatment on neurological function outcomes will be evaluated by mRS,NIHSS,MMSE (modified Rankin Scale,an scale used to assess levels of neurological impairment; The National Institute of Health stroke scale, a standardized method used by physicians and other health care professionals to measure the level of impairment caused by a stroke; mini-mental state examination, a brief 30-point questionnaire test that is used to screen for cognitive impairment) tested 1, 3, 6, 9 and 12 months after the index procedure.


Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin group
Patients in atorvastatin group will received 40 mg atorvastatin daily from 3 days before the index procedure to 12 months after the procedure.
Drug: atorvastatin
Patients in atorvastatin group will received 80 mg atorvastatin daily from 3 days before the index procedure to 12 months after the procedure.
Other Name: atorvastatin
No Intervention: Control group
Patients in control group will receive 20mg atorvastatin daily treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1: Clinical inclusion criteria

    1. Subject is ≥18 years old
    2. Eligible for percutaneous endovascular intervention
    3. Documented severe (70%) symptomatic intracranial stenosis
    4. Acceptable candidate for intracranial stenting
    5. Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
    6. Subject willing to comply with all specified follow-up evaluations
  • 2: Angiographic Inclusion Criteria

    1. Target lesion located in intracranial internal artery, intracranial vertebral artery, basilar artery or middle cerebral artery
    2. Target lesion must be symptomatic
    3. Target lesion diameter stenosis ≥70%
    4. Reference vessel diameter (RVD): ≥2.0 mm to ≤6.0 mm
    5. Cumulative target lesion length (area to be treated must be completely coverable by one study stent) ≤30 mm
    6. Target lesion is presumed accessible by endovascular treatment.
    7. One non target lesion may be treated in a non target vessel
    8. Non-target lesion in non-target vessel must be treated with a commercially available stent.
    9. Treatment of a non target lesion (if performed) must be deemed a clinical angiographic success, without requiring use of unplanned additional stent(s).
    10. Treatment must be completed prior to treatment of target lesion

Exclusion Criteria:

  • Contraindication to ASA, or to both clopidogrel and ticlopidine
  • Known hypersensitivity to atorvastatin
  • Known allergy to stainless steel
  • Known allergy to platinum
  • Previous treatment of the target vessel with angioplasty
  • Previous treatment of the target vessel with stent
  • Previous treatment of any non target vessel with stent within 9 months of the index procedure
  • Planned endovascular treatment to post index procedure
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational intracranial atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
  • Cerebral infarction within 1 month prior to the index procedure
  • Myocardial infarction within the past 1 month
  • Uncontrollable malignant hypertension (>180/110 mmHg) before procedure
  • Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l)
  • Anticipated treatment with atorvastatin or other statins during the 12 months after the index procedure
  • Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure
  • Leukopenia (leukocyte count < 3.5 × 109/liter)
  • Thrombocytopenia (platelet count < 100,000/mm3)
  • Thrombocytosis (> 750,000/mm3)
  • Seizure 12 months before procedure
  • Intracranial tumor
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Male or female with known intention to procreate within 12 months after the index procedure
  • Positive pregnancy test within 7 days before the index procedure, or lactating
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit the subject's ability to comply with study follow-up requirements or impact the scientific integrity of the study
  • Currently participating in another investigational drug or device study
  • Current treatment, or past treatment within 6 months with atorvastatin or other statins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255852

Locations
China, Jiangsu
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Study Chair: Xinfeng Liu, MD Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Xinfeng Liu, Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01255852     History of Changes
Other Study ID Numbers: JLH2
Study First Received: December 3, 2010
Last Updated: February 7, 2014
Health Authority: China: Ministry of Health

Keywords provided by Jinling Hospital, China:
atorvastatin
intracranial artery stenting
restenosis

Additional relevant MeSH terms:
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014