NIH GUIDE, Volume 23, Number 16, April 29, 1994


P.T. 34


  Clinical Trial 

  Cardiovascular Diseases 

National Heart, Lung, and Blood Institute

The Lipid Metabolism-Atherogenesis Branch, Division of Heart and

Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI)

has a requirement for the establishment of clinical units to assess

whether hormonal replacement therapy and/or antioxidant treatment

will stabilize or inhibit progression and induce regression of

coronary plaques in women.  In addition, the mechanisms by which

these treatments may modify atherosclerosis in women will be

explored.  Angiographic changes will be primary endpoints of this

trial.  Other endpoints, such as carotid and intracoronary

ultrasound, magnetic resonance coronary angiography, assessment of

endothelial function, may be proposed and will be considered during

protocol development.  Quantitative computerized analysis of the

angiograms will be performed by a central laboratory.  In addition,

it is proposed to follow lipid and clotting parameters that will be

analyzed by a central laboratory facility.

The study population will consist of 450 postmenopausal women with

angiographically documented CAD defined as at least 30 percent but no

more than 75 percent occlusion of any single coronary artery.  In

order to assure that the study will provide meaningful data on

diverse racial/ethnic groups, the overall goal will be to recruit 50

percent minority women.  The following will be exclusion criteria:

(1) age over 75; (2) any condition that would compromise

participation in the study or the likelihood of obtaining exit

angiograms, such as a life-threatening disease or a chronic illness

likely to require frequent hospitalizations and/or treatment

adjustments which may affect outcome variables; (3) contraindications

to the use of any of the study interventions; and (4) clear need for

treatment with any of the interventions for this trial.  It is

estimated that 50 percent of eligible women requiring angiographic

evaluation will agree to participate in the study, and 50 percent of

these women will meet the angiographic criteria.  The study will have

a 2x2 factorial design and roughly equal numbers of eligible women

will be randomized into four treatment groups:  (1) both active

therapies (hormone replacement and antioxidant), (2) active hormone

replacement therapy and antioxidant placebo, (3) active antioxidant

therapy and hormone replacement placebo, and (4) double placebo plus

usual care.  It is expected that hormone replacement therapy will

consist of estrogen plus a progestin for most or all gynecologically

intact women, and unopposed estrogen for women with hysterectomies.

With regards to antioxidants, most likely a combination of vitamin E,

beta-carotene, and vitamin C will be used.  Allowing for 20 percent

attrition over three years of follow-up, it is anticipated that at

least 360 women will be analyzed at the end of the study.  Three to

five awards are anticipated.  These incrementally funded contracts

will be awarded for five years.  This is not a Request for Proposals

(RFP).  RFP No. NHLBI-HV-94-17 will be released on or about April 28,



RFP No. NIH-NHLBI-HV-94-17 will be released on or about April 28,

1994.  Written requests must include three self-addressed mailing

labels and must site RFP No. NIH-NHLBI-HV-94-17.  To insure timely

receipt of requests for RFP No. NHLBI-HV-94-17, facsimile requests

will be accepted.  Requests for copies of the RFP are to be sent to:

Shari L. Spencer

Contracts Operations Branch

National Heart, Lung, and Blood Institute

Federal Building, Room 4C04

Bethesda, MD  20892

Telephone:  (301) 496-6838

FAX:  (301) 496-9501


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