Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

Intracranial Arterial Diseases Clinical Trial

Official title:

Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02341794
• Other study ID #: 2900
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2015
• Last updated: January 17, 2015
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: January 2015
• Source: Tokyo Medical University
• Contact: Hitoshi Aizawa, MD, PhD
• Phone: +813-3342-6111
• Email: haizawa[@]tokyo-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.

Description:

The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female patients between 30 and 80 years of age.

2. Patients with noncardioembolic ischemic stroke

3. Patients with intracranial arterial stenosis =50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.

4. LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia

5. Patients taking clopidogrel as antiplatelet therapy when providing informed consent

6. Patients considered to be able to visit the study site

7. Patients who provided written informed consent

Exclusion Criteria:

1. Any haemorrhagic stroke or haemorrhagic infarction

2. Familial hypercholesterolemia

3. Patients with uncontrolled angina pectoris or congestive heart failure

4. Patients with severe liver or renal dysfunction

5. Patients with a malignant tumor requiring treatment

6. Patients with uncontrolled diabetes mellitus

7. Patients with secondary dyslipidemia (due to corticosteroid etc)

8. Patients with a history of myopathy

9. Patients considered by the investigator to be unsuitable for participating in this study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intracranial Arterial Diseases

Intervention

Drug:
• Rosuvastatin
Rosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L.

Locations

Country	Name	City	State
Japan	Tokyo Medical University	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of intracranial arterial stenosis after two years		6 months, 1 year and 2 years	No
Secondary	Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)		6 months, 1 year and 2 years	No
Secondary	Ischemic stroke or transient ischemic attack		6 months, 1 year and 2 years	No
Secondary	Intracerebral haemorrhage or subarachnoid haemorrhage		6 months, 1 year and 2 years	No
Secondary	Death from any cause		6 months, 1 year and 2 years	No
Secondary	Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events		6 months, 1 year and 2 years	No
Secondary	The change of percentage in LDL-C from baseline		6 months, 1 year and 2 years	No
Secondary	The change in HDL-C level from baseline		6 months, 1 year and 2 years	No
Secondary	Intracranial haemorrhage		6 months, 1 year and 2 years	No
Secondary	Number of cerebral microbleeds on MRI		6 months, 1 year and 2 years	No
Secondary	Carotid intima-media thickness		6 months, 1 year and 2 years	No
Secondary	Ankle brachial index		6 months, 1 year and 2 years	No
Secondary	Brachial-ankle pulse wave velocity		6 months, 1 year and 2 years	No
Secondary	Adverse events and adverse drug reactions		up to 2 years	Yes