Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00053

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Pfizer

5 Primary Sponsor

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

Boston Scientific

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof Cheuk Man Yu

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

iv Email

cmyu@cuhk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof Cheuk Man Yu

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

iv Email

cmyu@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Atherosclerotic plaque burden reduction in Native and Intervened coronary arteries as well as in other Major arteries by High Dose ATorvastatin ThErapy-A double blind, randomized study (ANIMATE)

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

ANIMATE

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-07-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Ischaemic Heart Disease Patients

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 Months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Atorvastatin 10 mg or 80 mg daily

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: *Patient with established CAD indicated for PCI *Plasma LDL-cholesterol level >2.6mmol/L or clinically indicated for statin therapy

ii Exclusion Criteria

Exclusion criteria: *Significant renal failure that preclude coronary angiography and PCI *Significant left main CAD with significant risk to IVUS *Less than 6 months survival

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2003-07-03

21 Target Sample Size

140

22 Recruitment Status

Complete

23 Primary Outcome

• Atherosclerotic plaque burden by IVUS in the diseased native coronary artery that does not require PC1** • Atherosclerotic plaque burden by IVUS and restenosis by both IVUS and QCA for the degree of neointimal hyperplasia in the post-PCI coronary artery • Neointimal thickness of the carotid and brachial artery • Brachial artery dilatation in response to hyperaemia, i.e. the flow-depend dilatation as an indicator of endotheial function **only apply to the IVUS arm

24 Secondary Outcome

• Coronary diameter and percentage stenosis by QCA • Cardiovascular event rate • Correlation of the degree of atherosclerotic plaque regression to symptoms and cardiovascular event rate

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19