NCT00000553

Brief Summary

To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (HDL) cholesterol.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1994

Typical duration for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
Last Updated

February 10, 2016

Status Verified

March 1, 2005

First QC Date

October 27, 1999

Last Update Submit

February 8, 2016

Conditions

Interventions

Eligibility Criteria

Age35 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with low HDL cholesterol, with at least one 50% stenotic coronary lesion or three 30% stenotic coronary lesions. Women range in age from 35 to less than 68 and men from 35 to less than 63.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (7)

  • Brown G, Stewart BF, Zhao XQ, Hillger LA, Poulin D, Albers JJ. What benefit can be derived from treating normocholesterolemic patients with coronary artery disease? Am J Cardiol. 1995 Sep 28;76(9):93C-97C. doi: 10.1016/s0002-9149(99)80477-9.

    PMID: 7572694BACKGROUND
  • Brown BG, Zhao XQ, Chait A, Frohlich J, Cheung M, Heise N, Dowdy A, DeAngelis D, Fisher LD, Albers J. Lipid altering or antioxidant vitamins for patients with coronary disease and very low HDL cholesterol? The HDL-Atherosclerosis Treatment Study Design. Can J Cardiol. 1998 Apr;14 Suppl A:6A-13A.

    PMID: 9594927BACKGROUND
  • Cheung MC, Wolfbauer G, Brown BG, Albers JJ. Relationship between plasma phospholipid transfer protein activity and HDL subclasses among patients with low HDL and cardiovascular disease. Atherosclerosis. 1999 Jan;142(1):201-5. doi: 10.1016/s0021-9150(98)00190-7.

    PMID: 9920522BACKGROUND
  • Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001 Nov 29;345(22):1583-92. doi: 10.1056/NEJMoa011090.

    PMID: 11757504BACKGROUND
  • Brown BG, Cheung MC, Lee AC, Zhao XQ, Chait A. Antioxidant vitamins and lipid therapy: end of a long romance? Arterioscler Thromb Vasc Biol. 2002 Oct 1;22(10):1535-46. doi: 10.1161/01.atv.0000034706.24149.95.

    PMID: 12377728BACKGROUND
  • Williams PT, Zhao XQ, Marcovina SM, Otvos JD, Brown BG, Krauss RM. Comparison of four methods of analysis of lipoprotein particle subfractions for their association with angiographic progression of coronary artery disease. Atherosclerosis. 2014 Apr;233(2):713-720. doi: 10.1016/j.atherosclerosis.2014.01.034. Epub 2014 Jan 30.

  • Williams PT, Zhao XQ, Marcovina SM, Brown BG, Krauss RM. Levels of cholesterol in small LDL particles predict atherosclerosis progression and incident CHD in the HDL-Atherosclerosis Treatment Study (HATS). PLoS One. 2013;8(2):e56782. doi: 10.1371/journal.pone.0056782. Epub 2013 Feb 27.

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

SimvastatinNiacinAntioxidants

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingBiological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Bruce Brown

    University of Washington

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1994

Study Completion

February 1, 2001

Last Updated

February 10, 2016

Record last verified: 2005-03