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AtherosclerosisPhase 3NCT00066898

ARISE - Aggressive Reduction of Inflammation Stops Events

A Phase 3 study testing AGI-1067 in people with Atherosclerosis and Coronary Artery Disease, run by AtheroGenics at 219 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AGI-1067
How many people
6,000 participants
Where
219 sitesin 4 countries
Study dates
Jun 2003to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

IRB-approved informed written consent must be provided by all subjects prior to screening and study entry.

  1. Inclusion Criteria
  2. Informed written consent from the subject prior to Screening
  3. Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization
  4. Male or female subjects in one of the two following groups:
  5. Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older
  6. Subjects (without diabetes mellitus) 55 years of age or older with one of the following additional risk factors: (i) Age 60 or older (ii) Low HDL-C as evidenced by: Male: HDL-C < 40 mg/dL or Female: HDL-C < 50 mg/dL (iii) Previous Myocardial Infarction (in addition to the index event), or diagnosis of Atherosclerosis in a non-coronary vessel (e.g. history of prior stroke, presence of PVD) (iv) Prior history of CHF (Congestive Heart Failure) or ejection fraction < 40%
  7. Females must be non-lactating and not of child bearing potential
  8. Exclusion Criteria
  9. Subjects who are hemodynamically or clinically unstable
  10. Subjects who have had a PCI in the last 30 days
  11. Subjects who have had coronary artery bypass (CABG) in the last 3 months
  12. Subjects on a waiting list for revascularization or revascularization already planned
  13. Current symptoms consistent with moderate or severe CHF despite medical therapy
  14. Clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy
  15. Uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy)
  16. Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
  17. Subjects taking and requiring continued therapy with drugs known to significantly prolong the QT interval (this will not include drugs associated with minor effect on the QT interval of less than 15 msec.)
  18. Life-threatening illness where the subject is not expected to survive for 2 years or any history of cancer or malignancy within the past 5 years except for basal cell carcinoma or squamous cell carcinoma of the skin
  19. A history of intolerance to probucol (Lorelco™)
  20. Unreliability as a study participant based on the Investigator's (or designee's) knowledge of the subject (e.g., alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
  21. Participation in any investigational drug study within 30 days prior to study entry, or expectation to participate in any other investigational drug study during the course of the ARISE study.
  22. Previous participation in a study involving AGI-1067

Trial locations and contacts

219 sites in 4 countries.

219 sites in 4 countries

United States128 sites

  • Compass Medical Associates

    Abington, Massachusetts

  • City Cardiology Associates

    Akron, Ohio

  • The Heart Care Group

    Allentown, Pennsylvania

  • Amarillo Heart Clinical Research Institute

    Amarillo, Texas

  • Pharma Tex Research

    Amarillo, Texas

  • Appleton Heart Inst

    Appleton, Wisconsin

  • Crawford Long Hospital

    Atlanta, Georgia

  • Emory University Hospital

    Atlanta, Georgia

  • Fuqua Hrt Cntr Piedmont Hosp

    Atlanta, Georgia

  • Androscoggin Cardiology

    Auburn, Maine

  • Austin Heart PA

    Austin, Texas

  • Midatlantic Cardiovascular Associates

    Baltimore, Maryland

  • Midatlantic Cardiovascular

    Baltimore, Maryland

  • Bluestem Cardiology

    Bartlesville, Oklahoma

  • Southeast Texas Cardiology Associates II

    Beaumont, Texas

  • Tri-State Medical Group

    Beaver, Pennsylvania

  • Midatlantic Cardiovascular

    Bel Air, Maryland

  • Cardiovascular Associates

    Birmingham, Alabama

  • Univ of Alabama at Birmingham

    Birmingham, Alabama

  • Heart Care Research Foundation

    Blue Island, Illinois

  • Idaho Cardiology Associates

    Boise, Idaho

  • Gary Brockington, MD

    Boston, Massachusetts

  • Connecticut Clinical Research

    Bridgeport, Connecticut

  • SUNY Downstate Health Science Ctr

    Brooklyn, New York

  • Daniel Gottlieb MD PS

    Burien, Washington

  • Lahey Clinic Med Cntr

    Burlington, Massachusetts

  • Professional Clinical Research

    Cadillac, Michigan

  • Capitol Interventional Cardiology

    Carmichael, California

  • Louisiana Heart Center

    Chalmette, Louisiana

  • Charleston Cardiology

    Charleston, South Carolina

  • Mid Carolina Cardiology Research Div

    Charlotte, North Carolina

  • Peryam and Kroll Healthcare

    Chicago, Illinois

  • Lindner Clinical Trial Center

    Cincinnati, Ohio

  • New Horizons Clinical Research

    Cincinnati, Ohio

  • Sterling Research Group

    Cincinnati, Ohio

  • Alpha Clinical Research

    Clarksville, Tennessee

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida

  • Pikes Peak Cardiology

    Colorado Springs, Colorado

  • Patuxent Medical Group

    Columbia, Maryland

  • Clinical Cardiovascular Research Cntr

    Dallas, Texas

  • Geisinger Medical Center

    Danville, Pennsylvania

  • Aurora Denver Cardiololgy Associates

    Denver, Colorado

  • Iowa Heart Center

    Des Moines, Iowa

  • Wisconsin Center for Clinical Research

    Elkhorn, Wisconsin

  • Cardiovascular Assoc of Delaware Valley

    Elmer, New Jersey

  • Escondido Cardiology

    Escondido, California

  • The Heart Group

    Evansville, Indiana

  • Welborn Clinic Research Center

    Evansville, Indiana

  • Heart and Vascular Clinic N CO

    Fort Collins, Colorado

  • SW Florida Heart Group

    Fort Myers, Florida

  • Parkview Hospital

    Fort Wayne, Indiana

  • Univ of Florida, Cardiology

    Gainesville, Florida

  • Internal Medicine of Greer

    Greer, South Carolina

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey

  • Kandra, Fierer, Kuskin Associates

    Harrisburg, Pennsylvania

  • Pentucket Med Assoc Inc

    Haverhill, Massachusetts

  • The Methodist Hospital

    Houston, Texas

  • The Heart Center/Oracle Research

    Huntsville, Alabama

  • Care Group St. Vincent Hosp of IN

    Indianapolis, Indiana

  • Univ of IA College of Medicine

    Iowa City, Iowa

  • Diagnostic Cardiology

    Jacksonville, Florida

  • Jacksonville Cntr Clin Research

    Jacksonville, Florida

  • Jacksonville Heart Center

    Jacksonville Beach, Florida

  • Research Inst of Middle America

    Jeffersonville, Indiana

  • Borgess Medical Center

    Kalamazoo, Michigan

  • N'Touch Research

    Kansas City, Missouri

  • Cardiovascular Research Foundation

    Knoxville, Tennessee

  • The Office of Dr. Richard Gilmore

    Lake Charles, Louisiana

  • Watson Clinic LLP

    Lakeland, Florida

  • Nebraska Heart Institute

    Lincoln, Nebraska

  • The Office of Dr. Keith Pierce

    Livonia, Michigan

  • Cardiovascular Associates

    Louisville, Kentucky

  • Heart Clinic of Louisiana

    Marrero, Louisiana

  • Merced Heart Associates

    Merced, California

  • Tri City Cardiology Consultants

    Mesa, Arizona

  • Tri-City Cardiology Consultants

    Mesa, Arizona

  • Cardiovascular Research Center of South Florida

    Miami, Florida

  • Medical College of Wisconsin

    Milwaukee, Wisconsin

  • Cardiovascular Inst of the South

    Morgan City, Louisiana

  • Research Clinic

    Nassau Bay, Texas

  • Charles River Med Associates

    Natick, Massachusetts

  • Cardiovascular Inst of the South

    New Iberia, Louisiana

  • Louisiana Clinical Trials

    New Orleans, Louisiana

  • Tulane Univ Medical Center

    New Orleans, Louisiana

  • St Vincent's Med Cntr NY

    New York, New York

  • Christiana Care Health Svcs

    Newark, Delaware

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma

  • Creighton Cardiac Center

    Omaha, Nebraska

  • Orange County Research Cntr

    Orange, California

  • Orlando Heart Cntr

    Orlando, Florida

  • MD Med Research Ong Med Cntr

    Oxon Hill, Maryland

  • Nebraska Heart Institute

    Papillion, Nebraska

  • Heartcare Midwest Heart Inst

    Peoria, Illinois

  • Hope Research Institute

    Phoenix, Arizona

  • Lovelace Scientific Resources

    Phoenix, Arizona

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania

  • Banksville Medical

    Pittsburgh, Pennsylvania

  • ARI Clinical Trials

    Redondo Beach, California

  • Harbin Clinic

    Rome, Georgia

  • Beaumont Medical Office Bldg

    Royal Oak, Michigan

  • St Paul Heart Clinic

    Saint Paul, Minnesota

  • Heart Center

    Salt Lake City, Utah

  • IHC Health Services

    Salt Lake City, Utah

  • Sioco Cardiology, PA

    San Antonio, Texas

  • North Ohio Heart Center

    Sandusky, Ohio

  • Radiant Research

    Santa Rosa, California

  • Cardiovascular Cntr of Sarasota

    Sarasota, Florida

  • Sonoran Health Specialists

    Scottsdale, Arizona

  • U of WA NW Lipid Research Cntr

    Seattle, Washington

  • Medical Research Institute

    Slidell, Louisiana

  • DUCCS Research of S Boston

    South Boston, Virginia

  • St Louis Univ Div Solutions

    St Louis, Missouri

  • St Louis Univ Hospital

    St Louis, Missouri

  • Washington Univ School of Med

    St Louis, Missouri

  • SUNY Upstate Medical Univ

    Syracuse, New York

  • Syracuse Preventive Cardiology

    Syracuse, New York

  • The Broward Heart Group

    Tamarac, Florida

  • Clinical Research of West Florida, Inc.

    Tampa, Florida

  • Cardiovascular Inst of South

    Thibodaux, Louisiana

  • Midatlantic Cardiovascular

    Towson, Maryland

  • Michigan Heart Group

    Troy, Michigan

  • Cardiac Specialists, PC

    Trumbull, Connecticut

  • Castlerock Clinical Research Consultants

    Tulsa, Oklahoma

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin

  • Midatlantic Cardiovascular

    Westminster, Maryland

  • Research Inst of Kansas Inc

    Wichita, Kansas

  • Buffalo Cardiology and Pulmonary Associates

    Williamsville, New York

  • Rhode Island Cardiovascular Group

    Woonsocket, Rhode Island

Other trials in United States

Canada54 sites

  • Halton Heart Institute

    Burlington, Ontario

  • Foothills Hospital Cardiology Div

    Calgary, Alberta

  • CMGC-GRID Complexe Hosp

    Chicoutimi, Quebec

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • Q & T Research Outaouais

    Gatineau, Quebec

  • Recherches Cliniques Theradev

    Granby, Quebec

  • The Office of Dr. Syan Gurcharan

    Greater Sudbury, Ontario

  • The Office of Dr. Jean-Robert Timothee

    Greenfield Park, Quebec

  • ViaCar Recherche Clinique

    Greenfield Park, Quebec

  • Queen Elizabeth Health Sciences Centre

    Halifax, Nova Scotia

  • St Joseph Health Care Hamilton

    Hamilton, Ontario

  • Hosp Regional de Lanaudiere

    Joliette, Quebec

  • Kingston Heart Clinic

    Kingston, Ontario

  • Cite de la Sante de Laval

    Laval, Quebec

  • Clinique de Cardiologie de Levis

    Lévis, Quebec

  • London Health Sci Cntr Site

    London, Ontario

  • Mount St. Joseph's

    London, Ontario

  • Medicayeb, Inc.

    Longueuil, Quebec

  • ViaCar Recherche Clinique Inc.

    Longueuil, Quebec

  • CHUM Hopital Notre Dame

    Montreal, Quebec

  • CUSM Montreal General Hosp

    Montreal, Quebec

  • Hopital du Sacre Coeur De Montreal

    Montreal, Quebec

  • Maisonneuve Rosemont Hosp

    Montreal, Quebec

  • McGill Univ Health Cntr

    Montreal, Quebec

  • Medi-Recherche Inc.

    Montreal, Quebec

  • Montreal Heart Institute

    Montreal, Quebec

  • West Coast Cardiology Research

    New Westminster, British Columbia

  • Newmarket Cardiology Research

    Newmarket, Ontario

  • Heart Care Research

    Oshawa, Ontario

  • Ottawa Cardiovascular Center

    Ottawa, Ontario

  • Vexler Health Services

    Ottawa, Ontario

  • Recherches Clinicar

    Québec, Quebec

  • Pasqua Hosp Coronary Care Unit

    Regina, Saskatchewan

  • Cntr Hospital Beauce Etchemin

    Saint George, Quebec

  • Reseau Sante Richelieu Yamaska

    Saint-Hyacinthe, Quebec

  • Hopital du Haut-Richelieu

    Saint-Jean-sur-Richelieu, Quebec

  • Zoom International

    Saint-Jérôme, Quebec

  • Neufort Inc.

    Saint-Lambert, Quebec

  • Royal University Hospital

    Saskatoon, Saskatchewan

  • Saskatoon Medical Specialists

    Saskatoon, Saskatchewan

  • London Clinical Research

    Sherbrooke, Quebec

  • Health Sciences Centre Div of Cardiology

    St. John's, Newfoundland and Labrador

  • Laval Hospital Pavillion 2U

    Ste-Foy, Quebec

  • Cntr Hospitalier Pierre Le Gardeur

    Terrebonne, Quebec

  • Cliks Medical Research

    Thunder Bay, Ontario

  • Thunder Bay Regional Health Science Ctr

    Thunder Bay, Ontario

  • Mount Sinai Hospital

    Toronto, Ontario

  • Sunnybrook and Women's College

    Toronto, Ontario

  • University Health Network - Toronto Western Hosp

    Toronto, Ontario

  • Centre Hospitalier de Val d'Or

    Val-d'Or, Quebec

  • Vancouver General Hospital

    Vancouver, British Columbia

  • Societe des internistes Bois Fran

    Victoriaville, Quebec

  • Health Sciences Centre

    Winnipeg, Manitoba

  • St Boniface General Hospital

    Winnipeg, Manitoba

Other trials in Canada

South Africa19 sites

  • Pretoria Heart Hospital

    Arcadia, PTA

  • Dr. Johann Viljoen

    Bloemfontein, BLM

  • Fichmed 5, Rosepark Hospital

    Bloemfontein, BLM

  • Universitas Hospital

    Bloemfontein, BLM

  • Chatsmed Garden Hospital

    Chatsworth, DBN

  • Chatsmed Hospital

    Chatsworth, DBN

  • 403 Maxwell Centre

    Durban, DBN

  • United House

    Fordsburg, JHB

  • The Boulders Shopping Center

    Halfway House, JHB

  • Unitas Hospital

    Lyttelton Centurion, PTA

  • Mulbarton Medical Center

    Mulbarton, JHB

  • Olivedale Clinic

    Olivedale, JHB

  • 228 Panorama Medi Clinic

    Panorama, CT

  • Panorama Medical Clinic

    Panorama, CT

  • Tygerberg Hospital

    Parow, CT

  • Vincent Pallotti Hospital

    Pinelands, CT

  • Vergelegen Medical Clinic

    Somerset West, CT

  • Sunninghill Hospital

    Sunninghill, JHB

  • Wilgers Medical Consortium

    The Willows, PTA

Other trials in South Africa

United Kingdom18 sites

  • Grampian University Hospitals NHS Trust

    Aberdeen

  • Sandwell & West Birmingham City Hospital NHS Trust

    Birmingham

  • Papworth Hospital NHS Trust

    Cambridge

  • The Lothian University Hospitals NHS Trust

    Edinburgh

  • North Glasglow University Hospitals NHS Trust

    Glasglow

  • South Glasglow University Hospital NHS Trust

    Glasglow

  • Western Infirmary Glaglow

    Glasglow

  • The Leeds Teaching Hospitals NHS Trust

    Leeds

  • University Hospitals of Leicester NHS Trust

    Leicester

  • Liverpool NHS Trust

    Liverpool

  • King's College Hospital NHS Trust

    London, England

  • South Manchester University Hospitals NHS Trust

    Manchester

  • Argyll & Clyde NHS Trust

    Paisley

  • Barking, Havering & Redbridge Hospital NHS Trust

    Romford, Essex

  • Sheffield Teaching Hospitals NHS Trust

    Sheffield

  • Forth Valley Acute Hospitals NHS Trust

    Stirling

  • University Hospitals of North Staffordshire NHS Trust

    Stoke-on-Trent

  • Mid Yorkshire Hospitals

    Wakefield

Other trials in United Kingdom

About this study

Official title: "Reduction of Vascular Inflammation and Coronary Atherosclerosis With AGI-1067, a V-Protectant, Reduces Cardiovascular Events in Patients With Coronary Artery Disease"

To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events.

Read the detailed description

This study will be a Phase III multi-center, double-blind, parallel group, placebo-controlled trial involving approximately 260 study sites in the United States, Canada, South Africa and the United Kingdom. It is expected that approximately 6,600 subjects will be screened in order to randomize approximately 6,000 subjects globally (3,000 in each arm of the study). Male or female subjects with coronary artery disease are eligible to participate if they meet all required inclusion and exclusion criteria. Recruitment will be delayed for one month in subjects who have had a PCI. Subjects who have a PCI planned at the time of screening or randomization, will not be randomized until one month after this planned PCI has been conducted. All subjects who successfully complete the screening phase and meet all required inclusion and exclusion criteria will be entered into the single-blind, placebo Run-In phase of the study to establish compliance. The placebo Run-In medication will be identical to the blinded study drug used in the randomized portion of the study. After the completion of the two-week Run-In, if compliance has been adequate, study subjects will be randomized to receive AGI-1067 300 mg (two 150 mg tablets daily with a meal) or placebo (approximately equal numbers of subjects per treatment group) for a minimum of 12 months. It is anticipated that subject accrual will occur over a period of approximately 24 months and that all subjects will be followed until at least 990 subjects have experienced a primary event. Subjects will remain on drug therapy from randomization until the end of the study. It is estimated that the first subject recruited will be exposed to blinded therapy for 30 to 36 months, and the last subject will be exposed for a minimum of 6 to 12 months. For the purposes of this study one month will be equal to 28 days. The subject will be asked to return to the clinic at 1 month, 3 months, and every 3 months thereafter during the treatment phase. All clinical laboratory procedures and electrocardiographic interpretations will be performed by central laboratories. Over the study period, subjects will be followed for the occurrence of major adverse cardiovascular events. These potential endpoints will be adjudicated by an independent endpoint committee. This committee will consist of cardiologists and other physician reviewers who will be blinded to the treatment. For the purposes of safety, the trial will be monitored by an independent Data Safety Monitoring Board. This Board will consist of Cardiologists, and at least one Statistician experienced in the conduct of clinical trials. The Board will meet approximately every 6 months to review subject safety data.

Being tested
AGI-1067
Keywords
succinobucol, AGI-1067, coronary artery disease
Medical subject headings
Atherosclerosis, Coronary Artery Disease, Myocardial Infarction, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGI-1067Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of time to the first occurrence of one of six adjudicated events: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for angina pectoris, or use of coronary revascularization.

Secondary outcomes (3)

  1. Time to first incidence of any of the following: all cause mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, use of coronary revascularization, and hospitalization for unstable angina

  2. Time to first incidence of any of the following: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina

  3. Time to first incidence of any of the following: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, and non-fatal stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
6,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066898
Sponsor's protocol ID
AGI-1067/042
Status last verified
Sep 2006
First submitted
6 Aug 2003
Last updated
3 Oct 2006
Results posted
No

Publications

  • Tardif JC, McMurray JJ, Klug E, Small R, Schumi J, Choi J, Cooper J, Scott R, Lewis EF, L'Allier PL, Pfeffer MA; Aggressive Reduction of Inflammation Stops Events (ARISE) Trial Investigators. Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 May 24;371(9626):1761-8. doi: 10.1016/S0140-6736(08)60763-1.

    PubMed 18502300

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AGI-1067 in people with Atherosclerosis and Coronary Artery Disease, run by AtheroGenics at 219 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, Canada, South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of time to the first occurrence of one of six adjudicated events: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for angina pectoris, or use of coronary revascularization.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066898, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2006.

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