Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting

NCT01255852 | Completed Phase 4 DMC

• 1 other identifier: JLH2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CVD

Keywords

atorvastatin; intracranial artery stenting; restenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  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.

  at two year

Secondary Outcomes (5)

• Clinical endpoint

  at two years

• Angiographic follow-up

  at two years

• In-segment binary restenosis rate 12 months after the index procedure

  at two years

• Effects of atorvastatin on blood lipid and inflammatory levels

  at two years

• Effects of atorvastatin treatment on neurological function outcomes

  at two years

Study Arms (2)

Atorvastatin group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in control group will receive 20mg atorvastatin daily treatment.

Interventions

atorvastatin DRUG

Patients in atorvastatin group will received 80 mg atorvastatin daily from 3 days before the index procedure to 12 months after the procedure.

Atorvastatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years old
• Eligible for percutaneous endovascular intervention
• Documented severe (70%) symptomatic intracranial stenosis
• Acceptable candidate for intracranial stenting
• 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
• Subject willing to comply with all specified follow-up evaluations
• Target lesion located in intracranial internal artery, intracranial vertebral artery, basilar artery or middle cerebral artery
• Target lesion must be symptomatic
• Target lesion diameter stenosis ≥70%
• Reference vessel diameter (RVD): ≥2.0 mm to ≤6.0 mm
• Cumulative target lesion length (area to be treated must be completely coverable by one study stent) ≤30 mm
• Target lesion is presumed accessible by endovascular treatment.
• One non target lesion may be treated in a non target vessel
• Non-target lesion in non-target vessel must be treated with a commercially available stent.
• Treatment of a non target lesion (if performed) must be deemed a clinical angiographic success, without requiring use of unplanned additional stent(s).

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Xinfeng Liu, MD

  Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Atorvastatin for Preventing Occlusion and Restenosis After Intracranial Artery Stenting

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 8, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

CN (1)