Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting (APORIAS)
This study has been completed.
First Posted: December 8, 2010
Last Update Posted: September 2, 2015
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Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
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.
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
||Phase 4 of Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting
Primary Outcome Measures:
- Target lesion failure [ Time Frame: at two year ]
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 ]
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 ]
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 ]
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 ]
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 ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
Patients in atorvastatin group will received 80 mg atorvastatin daily from 3 days before the index procedure to 12 months after the procedure.
No Intervention: Control group
Patients in control group will receive 20mg atorvastatin daily treatment.
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|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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): NCT01255852
|Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
|Nanjing, Jiangsu, China, 210002 |
Jinling Hospital, China
||Xinfeng Liu, MD
||Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
||Xinfeng Liu, Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting, Jinling Hospital, China
History of Changes
|Other Study ID Numbers:
||December 3, 2010
||December 8, 2010
|Last Update Posted:
||September 2, 2015
Keywords provided by Xinfeng Liu, Jinling Hospital, China:
intracranial artery stenting
Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors