UMIN-CTR Clinical Trial

Public title

Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)

Acronym

ARIS study

Scientific Title

Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)

Scientific Title:Acronym

ARIS study

Region

Japan

Condition

Hypercholesterolemia coupled with ischemic stroke

Classification by specialty

Cardiology	Endocrinology and Metabolism	Neurology
Vascular surgery	Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effects of atorvastatin and rosuvastatin on lipid and inflammatory markers (high-sensitivity CRP) in ischemic stroke patients with hypercholesterolemia

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The percent change of LDL-C, HDL-C, TG and high-sensitivity CRP composition after 12 months

Key secondary outcomes

1) Percent change of LDL-C/HDL-C ratio
2) Percent change of non HDL-C
3) Major adverse cardiac and cerebrovascular events
4) Changes in intima-media thickness (max and mean IMT)
5) Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rosuvastatin will be administered within 7 days after ischemic stroke onset and continued for 12 months at a dosage of 5mg/day. If treatment fails to reduce the LDL-C level enough, the dosage can be increased.

Interventions/Control_2

Atorvastatin will be administered within 7 days after ischemic stroke onset and continued for 12 months at a dosage of 10mg/day. If treatment fails to reduce the LDL-C level enough, the dosage can be increased.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients within 7 days of stroke onset
2) Patients with the LDL-C level of more than 120 mg/dL
3) Patients aged 20 years or older at the time of giving consent
4) No limitations on gender or hospitalization status
5) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial

Key exclusion criteria

1) Patients with Japan Coma Scale (JCS) greater than 10 (Patients who cannot take foods orally)
2) Patients who have received atorvastatin or rosuvastatin before the observation period
3) Patients with familial hypercholesterolemia or secondary hyperlipidemia
4) Patients with the fasting TG level of more than 400 mg/dL
5) Patients with hypersensitivity to HMG-CoA reductase inhibitor(statin)
6) Patients within 3 months of stroke onset
7) Patients with active liver disease (ALT or AST levels more than 100IU/L, or a total bilirubin of more than 2.5 mg/dL)
8) Patients with renal dysfunction (the serum creatinine more than 2.0 mg/dL or Ccr<30mL/min/1.73 square meter)
9) Patients with the serum creatine kinase (CK) levels greater than 500IU/L
10) Patients on treatment with cyclosporine
11) Pregnant and potential pregnancy
12) Patients with hypothyroidism, hereditary myopathy (muscular dystrophy) or family history of hereditary myopathy, and drug-induced myopathy
13) Patients with drug abuse or alcoholism
14) Patients who are ineligible for any other reason in the opinion of the investigator

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Takahisa Mori

Organization

Shonan Kamakura General Hospital

Division name

Deaprtment of Stroke Treatment

Zip code

Address

Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan

TEL

0467-46-1717

Email

Name of contact person

1st name
Middle name
Last name	Yuichi Miyazaki

Organization

Shonan Kamakura General Hospital

Division name

Department of Stroke Treatment

Zip code

Address

Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan

TEL

0467-46-1717

Homepage URL

Email

Institute

Department of Stroke Treatment,Shonan Kamakura General Hospital

Institute

Department

Personal name

Organization

Shonan Kamakura General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

湘南鎌倉総合病院脳卒中診療科

Date of disclosure of the study information

2010

Year

11

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2010

Year

10

Month

31

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

23

Day

Last modified on

2012

Year

06

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005502