NCT00000463

Brief Summary

To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1987

Longer than P75 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

April 1, 1987

Completed
11.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
11 months 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
Last Updated

April 14, 2016

Status Verified

August 1, 2004

First QC Date

October 27, 1999

Last Update Submit

April 12, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women between 1 and 11 years post-CABG. Patients had two completely independent saphenous vein grafts that were patent. Patients had an LDL-cholesterol between 130 and 175 with plasma triglycerides below 300 mg/dl.

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

Sponsors & Collaborators

Related Publications (21)

  • Healy B, Campeau L, Gray R, Herd JA, Hoogwerf B, Hunninghake D, Knatterud G, Stewart W, White C. Conflict-of-interest guidelines for a multicenter clinical trial of treatment after coronary-artery bypass-graft surgery. N Engl J Med. 1989 Apr 6;320(14):949-51. doi: 10.1056/NEJM198904063201432. No abstract available.

    PMID: 2784541BACKGROUND
  • Fox NL, LoPresti F, Hoogwerf B, Knatterud G, Linquist R, Czajkowski S. Self-administered quality of life forms: experience from the Post Coronary Artery Bypass Graft Studies. Controlled Clin Trials 1993;14:402.

    BACKGROUND
  • Shenberger DM, Helgren RJ, Peters JR, Quiter E, Johnston EA, Hunninghake DB. Intense dietary counseling lowers LDL cholesterol in the recruitment phase of a clinical trial of men who had coronary artery bypass grafts. J Am Diet Assoc. 1992 Apr;92(4):441-5.

    PMID: 1556345BACKGROUND
  • Campeau L, Knatterud GL, White C, Domanski M, Geller N, Robernsberg Y and the Post CABG Studies Principal Investigators. The NHLBI Post Coronary Artery Bypass Graft Clinical Trial (Post CABG): Angiographic outcomes. Proceedings of the colloquium "Progression and Regression of Coronary Atherosclerosis: Observations from Lipid Intervention Studies," In Press

    BACKGROUND
  • Post Coronary Artery Bypass Graft Trial Investigators. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. N Engl J Med. 1997 Jan 16;336(3):153-62. doi: 10.1056/NEJM199701163360301.

    PMID: 8992351BACKGROUND
  • Fuster V, Vorchheimer DA. Prevention of atherosclerosis in coronary-artery bypass grafts. N Engl J Med. 1997 Jan 16;336(3):212-3. doi: 10.1056/NEJM199701163360309. No abstract available.

    PMID: 8988902BACKGROUND
  • Czajkowski SM, Terrin M, Lindquist R, Hoogwerf B, Dupuis G, Shumaker SA, Gray JR, Herd JA, Treat-Jacobson D, Zyzanski S, Knatterud GL. Comparison of preoperative characteristics of men and women undergoing coronary artery bypass grafting (the Post Coronary Artery Bypass Graft [CABG] Biobehavioral Study). Am J Cardiol. 1997 Apr 15;79(8):1017-24. doi: 10.1016/s0002-9149(97)00040-4.

    PMID: 9114757BACKGROUND
  • Canner PL, Thompson B, Knatterud GL, Geller N, Campeau L, Zucker D. An application of the Zucker-Wittes modified ratio estimate statistic in the Post Coronary Artery Bypass Graft (CABG) clinical trial. Control Clin Trials. 1997 Aug;18(4):318-27. doi: 10.1016/s0197-2456(96)00232-2.

    PMID: 9257071BACKGROUND
  • Hoogwerf BJ, Waness A, Cressman M, Canner J, Campeau L, Domanski M, Geller N, Herd A, Hickey A, Hunninghake DB, Knatterud GL, White C. Effects of aggressive cholesterol lowering and low-dose anticoagulation on clinical and angiographic outcomes in patients with diabetes: the Post Coronary Artery Bypass Graft Trial. Diabetes. 1999 Jun;48(6):1289-94. doi: 10.2337/diabetes.48.6.1289.

    PMID: 10342818BACKGROUND
  • Gobel FL, Stewart WJ, Campeau L, Hickey A, Herd JA, Forman S, White CW, Rosenberg Y. Safety of coronary arteriography in clinically stable patients following coronary bypass surgery. Post CABG Clinical Trial Investigators. Cathet Cardiovasc Diagn. 1998 Dec;45(4):376-81. doi: 10.1002/(sici)1097-0304(199812)45:43.0.co;2-x.

    PMID: 9863740BACKGROUND
  • Hunninghake DB. Is aggressive cholesterol control justified? Review of the post-coronary artery bypass graft trial. Am J Cardiol. 1998 Nov 26;82(10B):45T-48T. doi: 10.1016/s0002-9149(98)00725-5.

    PMID: 9860374BACKGROUND
  • Knatterud GL, Rosenberg Y, Campeau L, Geller NL, Hunninghake DB, Forman SA, Forrester JS, Gobel FL, Herd JA, Hickey A, Hoogwerf BJ, Terrin ML, White C. Long-term effects on clinical outcomes of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation in the post coronary artery bypass graft trial. Post CABG Investigators. Circulation. 2000 Jul 11;102(2):157-65. doi: 10.1161/01.cir.102.2.157.

    PMID: 10889125BACKGROUND
  • Domanski MJ, Borkowf CB, Campeau L, Knatterud GL, White C, Hoogwerf B, Rosenberg Y, Geller NL. Prognostic factors for atherosclerosis progression in saphenous vein grafts: the postcoronary artery bypass graft (Post-CABG) trial. Post-CABG Trial Investigators. J Am Coll Cardiol. 2000 Nov 15;36(6):1877-83. doi: 10.1016/s0735-1097(00)00973-6.

    PMID: 11092659BACKGROUND
  • Campeau L, Hunninghake DB, Knatterud GL, White CW, Domanski M, Forman SA, Forrester JS, Geller NL, Gobel FL, Herd JA, Hoogwerf BJ, Rosenberg Y. Aggressive cholesterol lowering delays saphenous vein graft atherosclerosis in women, the elderly, and patients with associated risk factors. NHLBI post coronary artery bypass graft clinical trial. Post CABG Trial Investigators. Circulation. 1999 Jun 29;99(25):3241-7. doi: 10.1161/01.cir.99.25.3241.

    PMID: 10385497BACKGROUND
  • Alaupovic P, Fesmire JD, Hunnighake D, Domanski M, Forman S, Knatterud GL, Forrester J, Herd JA, Hoogwerf B, Campeau L, Gobel FL. The effect of aggressive and moderate lowering of LDL-cholesterol and low dose anticoagulation on plasma lipids, apolipoproteins and lipoprotein families in post coronary artery bypass graft trial. Atherosclerosis. 1999 Oct;146(2):369-79. doi: 10.1016/s0021-9150(99)00151-3.

    PMID: 10532693BACKGROUND
  • White CW, Campeau L, Canner P, Domanski M, Forrester JS, Gobel FL, Herd JA, Hoogwerf BJ, Hunninghake DB, Knatterud GL, LoPresti F; Post CABG Investigators. Lessons from the post coronary artery bypass graft study in evaluating and controlling technical variability in angiographic trials. Post CABG Investigators. Am J Cardiol. 2001 Jan 1;87(1):40-3. doi: 10.1016/s0002-9149(00)01269-8.

    PMID: 11137831BACKGROUND
  • White CW, Gobel FL, Campeau L, Knatterud GL, Forman SA, Forrester JS, Geller NL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Rosenberg Y, Terrin ML; Post Coronary Artery Bypass Graft Trial Investigators. Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001 Nov 27;104(22):2660-5. doi: 10.1161/hc4701.099730.

    PMID: 11723015BACKGROUND
  • Herd JA, Hoogwerf BJ, Barton F, Terrin ML, Czajkowski SM, Lindquist R, Dupuis G. Heart rate and blood pressure responses to mental stress and clinical cardiovascular events in men and women after coronary artery bypass grafting: the Post Coronary Artery Bypass Graft (Post-CABG) biobehavioral study. Am Heart J. 2003 Aug;146(2):273-9. doi: 10.1016/S0002-8703(03)00182-0.

    PMID: 12891195BACKGROUND
  • Lindquist R, Dupuis G, Terrin ML, Hoogwerf B, Czajkowski S, Herd JA, Barton FB, Tracy MF, Hunninghake DB, Treat-Jacobson D, Shumaker S, Zyzanski S, Goldenberg I, Knatterud GL; POST CABG Biobehavioral Study Investigators. Comparison of health-related quality-of-life outcomes of men and women after coronary artery bypass surgery through 1 year: findings from the POST CABG Biobehavioral Study. Am Heart J. 2003 Dec;146(6):1038-44. doi: 10.1016/S0002-8703(03)00451-4.

    PMID: 14660996BACKGROUND
  • Campeau L, Knatterud G, Hunninghake B, Domanski M. Optimizing cholesterol lowering therapy: contribution of the Post Coronary Artery Bypass Graft Trial. Eur Heart J. 1997 Nov;18(11):1683-5. doi: 10.1093/oxfordjournals.eurheartj.a015155. No abstract available.

    PMID: 9402435BACKGROUND
  • Fox NL, Hoogwerf BJ, Czajkowski S, Lindquist R, Dupuis G, Herd JA, Campeau L, Hickey A, Barton FB, Terrin ML; POST CABG Study Investigators. Quality of life after coronary artery bypass graft: results from the POST CABG Trial. Chest. 2004 Aug;126(2):487-95. doi: 10.1378/chest.126.2.487.

    PMID: 15302735BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

LovastatinCholestyramine ResinWarfarin

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPolystyrenesPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Genell Knatterud

    Maryland Medical Research Institute

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1987

Study Completion

December 1, 1998

Last Updated

April 14, 2016

Record last verified: 2004-08