NIH GUIDE, Volume 21, Number 43, November 27, 1992


P.T. 34, II


  Clinical Trial 

  Cardiovascular Diseases 

  Medical/Diagnostic Imaging 


National Heart, Lung, and Blood Institute

The primary objective of this project is to assess whether or not

interventions that modify lipoproteins will inhibit progression and

induce regression of coronary plaques in women; the secondary

objective is to elucidate the mechanisms by which various treatments

may modify atherosclerosis in women.  The study will consist of three

randomized angiographic trials with a common core protocol and a

single Clinical Coordinating Center.  Angiographic changes will be

primary endpoints of all three trials.  A total of 568 women with

angiographically documented coronary artery disease will be enrolled

to participate in one of three randomized therapeutic trials:  (1)

Hormone replacement therapy in postmenopausal women; (2)

Cholesterol-lowering diet and antioxidants; and (3) Drugs that lower

LDL-cholesterol versus drugs that, in addition, raise HDL-cholesterol

levels.  Angiographic changes will be primary endpoints of all three

trials.  Quantitative computerized analysis of the angiograms will be

performed by a central angiographic facility.  In addition, it is

proposed to follow lipid and clotting parameters, which will be

analyzed by a central laboratory facility.  The study population for

the first and third trials will consist of 208 women, and the second,

152 women, with angiographically documented CAD defined as at least

30 percent but no more than 75 percent occlusion of any single

coronary artery.  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 that 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.  Three to six awards are anticipated. These

incrementally funded contracts will be awarded for five years.

This announcement is not a request for proposals (RFP).  RFP

NHLBI-HV-92-43 will be released on or about November 25, 1992 with

proposals due on or about February 1, 1993.  Written request must

include three self-addressed mailing labels and must cite RFP No.



Request for copies of the RFP are to be sent to:

Sharon M. Kraft, Contract Specialist

HLVD Contracts Section, COB, DEA

National Heart, Lung, and Blood Institute

Bethesda, MD  20892

Telephone:  (301) 496-6815


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