Asymptomatic Carotid Artery Plaque Study (ACAPS)

NCT00000469 | Completed Phase 2

• 2 other identifiers: 58R01HL038194
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether warfarin or lovastatin alone or in combination retarded the progression of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic carotid stenosis. Also, to determine if a full scale trial was feasible.

Conditions

Cardiovascular Diseases; Carotid Stenosis; Cerebral Arteriosclerosis; Cerebrovascular Disorders; Heart Diseases; Vascular Diseases

Interventions

aspirin DRUG

lovastatin DRUG

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men and women with early carotid atherosclerosis and moderately elevated LDL cholesterol between the 60th and 90th percentiles.

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (11)

• Espeland MA, Craven TE, Riley WA, Corson J, Romont A, Furberg CD. Reliability of longitudinal ultrasonographic measurements of carotid intimal-medial thicknesses. Asymptomatic Carotid Artery Progression Study Research Group. Stroke. 1996 Mar;27(3):480-5. doi: 10.1161/01.str.27.3.480.

  PMID: 8610317 BACKGROUND

• Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). The ACAPS Group. Control Clin Trials. 1992 Aug;13(4):293-314. doi: 10.1016/0197-2456(92)90012-o.

  PMID: 1330434 BACKGROUND

• Espeland MA, Byington RP, Hire D, Davis VG, Hartwell T, Probstfield J. Analysis strategies for serial multivariate ultrasonographic data that are incomplete. Stat Med. 1992 Jun 15;11(8):1041-56. doi: 10.1002/sim.4780110806.

  PMID: 1496192 BACKGROUND

• Riley WA, Barnes RW, Applegate WB, Dempsey R, Hartwell T, Davis VG, Bond MG, Furberg CD. Reproducibility of noninvasive ultrasonic measurement of carotid atherosclerosis. The Asymptomatic Carotid Artery Plaque Study. Stroke. 1992 Aug;23(8):1062-8. doi: 10.1161/01.str.23.8.1062.

  PMID: 1636178 BACKGROUND

• Espeland MA, Hoen H, Byington R, Howard G, Riley WA, Furberg CD. Spatial distribution of carotid intimal-medial thickness as measured by B-mode ultrasonography. Stroke. 1994 Sep;25(9):1812-9. doi: 10.1161/01.str.25.9.1812.

  PMID: 8073462 BACKGROUND

• Furberg CD, Adams HP Jr, Applegate WB, Byington RP, Espeland MA, Hartwell T, Hunninghake DB, Lefkowitz DS, Probstfield J, Riley WA, et al. Effect of lovastatin on early carotid atherosclerosis and cardiovascular events. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group. Circulation. 1994 Oct;90(4):1679-87. doi: 10.1161/01.cir.90.4.1679.

  PMID: 7734010 BACKGROUND

• Probstfield JL, Margitic SE, Byington RP, Espeland MA, Furberg CD. Results of the primary outcome measure and clinical events from the Asymptomatic Carotid Artery Progression Study. Am J Cardiol. 1995 Sep 28;76(9):47C-53C. doi: 10.1016/s0002-9149(99)80470-6.

  PMID: 7572686 BACKGROUND

• Espeland MA, Applegate W, Furberg CD, Lefkowitz D, Rice L, Hunninghake D. Estrogen replacement therapy and progression of intimal-medial thickness in the carotid arteries of postmenopausal women. ACAPS Investigators. Asymptomatic Carotid Atherosclerosis Progression Study. Am J Epidemiol. 1995 Nov 15;142(10):1011-9. doi: 10.1093/oxfordjournals.aje.a117553.

  PMID: 7485045 BACKGROUND

• Riley WA, Craven T, Romont A, Furberg CD. Assessment of temporal bias in longitudinal measurements of carotid intimal-medial thickness in the Asymptomatic Carotid Artery Progression Study (ACAPS). ACAPS Research Group. Ultrasound Med Biol. 1996;22(4):405-11. doi: 10.1016/0301-5629(96)00027-0.

  PMID: 8795167 BACKGROUND

• Byington RP, Evans GW, Espeland MA, Applegate WB, Hunninghake DB, Probstfield J, Furberg CD. Effects of lovastatin and warfarin on early carotid atherosclerosis: sex-specific analyses. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group. Circulation. 1999 Jul 20;100(3):e14-7. doi: 10.1161/01.cir.100.3.e14.

  PMID: 10411862 BACKGROUND

• Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

  PMID: 37565307 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Carotid Stenosis; Intracranial Arteriosclerosis; Cerebrovascular Disorders; Heart Diseases; Vascular Diseases

Interventions

Aspirin; Lovastatin

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Arteriosclerosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mark Espeland

  Bowman Gray School of Medicine

• Curt Furberg

  Bowman Gray School of Medicine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: May 1, 1988
• Study Completion: August 1, 1998
• Last Updated: May 13, 2016

Record last verified: 2000-04