UMIN-CTR Clinical Trial

Public title

Aggressive lipid-lowering treatment approaches for vulnerable plaque in coronary artery with rosuvastatin.
-Assessment using angioscopy and intravascular ultrasound -

Acronym

ALTAIR Study

Scientific Title

Aggressive lipid-lowering treatment approaches for vulnerable plaque in coronary artery with rosuvastatin.
-Assessment using angioscopy and intravascular ultrasound -

Scientific Title:Acronym

ALTAIR Study

Region

Japan

Condition

Hypercholesterolemia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the changes in LDL-C and coronary artery plaque in elective PCI patients with elevated LDL cholesterol following aggressive LDL-C lowering treatment in the high-dose rosuvastatin group, with those in the low-dose rosuvastatin group.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in yellow plaque

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

High-dose rosuvastatin group:
Weeks 0-4:
Rosuvastatin 10 mg administered orally once daily.*
From Week 4:
Rosuvastatin 20 mg administered orally once daily.*
* However, if LDL-C is < 50 mg/dL, continue treatment until Week 96 without increasing dose.

Interventions/Control_2

Low-dose rosuvastatin group:
Rosuvastatin 2.5 mg administered orally once daily.

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

Subjects
Patients with elevated LDL cholesterol and yellow plaque (>= Grade 2) in addition to the lesion in question, and who satisfy the following conditions will be admitted to this study:
1) Patients with dyslipidemia
Patients who do not meet the JAS guidelines (LDL-C: >= 100 mg/dL)
2) Male or female inpatients/outpatients who are at least 20 yrs at the time of consent
3) Patients who are capable of giving written consent
Target plaque
The lesion in question will be yellow plaque. Intravascular ultrasound (IVUS) and angio-endoscopy will evaluate the same region of the lesion. Moderately or severely calcified plaque, or other plaque which cannot be evaluated, will not be included in the study.

Key exclusion criteria

1) Patients whose onset of acute coronary syndrome is <= 24 h
2) Patients who will require bypass surgery <= 48 h
3) Patients with familial hypercholesterolemia or secondary hypercholesterolemia
4) Patients whose fasting serum is TG >= 400 mg/dL
5) Patients with a history of hypersensitivity to statins
6) Patients with serious diabetes mellitus (HbA1c >= 8.5%)
7) Patients with active liver disease (ALT or AST: > 100 IU/L, total bilirubin: > 2.5 mg/dL)
8) Patients with renal impairment (serum Cr >= 2.0 mg/dL or Ccr < 30 mL/min [Cockcroft-Gault formula])
9) Patients receiving ciclosporin treatment
10) Patients who are, or who may possibly be, pregnant
11) Patients with hypothyroidism, genetic muscular disorder (e.g., muscular dystrophy) or a family history thereof, patients with a history of drug-related muscular disorders
12) Patients who are drug abusers or alcoholics
13) Other patients whom the investigator considers unsuitable for inclusion in the study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Saito

Organization

Keiai hospital

Division name

Director

Zip code

Address

3-10-23 Mukaihara, Itabashi-ku, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

ALTAIR Study

Division name

ALTAIR Study

Zip code

Address

2-12-8 Shinjuku, Shinjuku-ku, Tokyo

TEL

Homepage URL

Email

Institute

ALTAIR Study

Institute

Department

Personal name

Organization

Japan Heart Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

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

Date of disclosure of the study information

2010

Year

03

Month

03

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

Completed

Date of protocol fixation

2010

Year

01

Month

08

Day

Date of IRB

Anticipated trial start date

2010

Year

09

Month

01

Day

Last follow-up date

2013

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

03

Month

02

Day

Last modified on

2014

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003968