Randomized trial of aspirin and beta-carotene in us mds

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Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Project Description:
We propose to conduct a five-year randomized, double-blind, placebo-controlled trial of the effect of alternate-day consumption of a ewt mg aspirin tablet primarily on cardiovascular mortality (but also on total mortality) among male U.S. physicians, 50 to 75 years of age. We mailed study materials to a random sample of 5000 subjects, and their replies indicated that we will enroll 21,900 apparently healthy men. Physicians who are eligible and willing to participate will be assigned at random to taking either a single 325 mg aspirin tablet or placebo every other day. Every six months participants will be sent new supplies in monthly calendar packs and follow-up questionnaires asking about their compliance and recent health. Deaths in all randomized subjects will be documented by death certificates. Under the null hypothesis we would expect about 500 cardiovascular deaths and over 1000 total deaths in each group during the 4 1/2 years of data collection. A Mantel-Haenszel pooled analysis of all trials completed to date, including AMIS, indicate approximately a 20% reduction in reinfarction (95% confidence limits +11% to -28%) and approximately a 9% reduction in total mortality (-4% to +18%). (Repeating this analysis using the AMIS values adjusted by the Cox procedure gives reductions of 24% in reinfarction and 13% in total mortality, both significant). Thus, under reasonable alternative hypotheses (ie, a 20% reduction due to aspirin), this trial will have power greater than 90%. A subsidiary aim will be to assess the effect of ingestion of beta-carotene on the risk of developing cancer in this same population. To do this, we will randomly assign half of each aspirin/placebo treatment group to taking one 30 mg capsule of either beta-carotene of its placebo every other day. Our pilot study results and our consideration of possible interactions indicate that we can accomplish this important scientific objective without affecting the sensitivity (or the cost) of the aspirin component. The study will thus be a 2x2 factorial in which each participant takes a single tablet or capsule daily.
 
Project Terms:
chemoprevention human therapy evaluation carotene cancer prevention physicians cardiovascular disorder prevention aspirin clinical trials nutrition related tag human subject
Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Project Categories:
• Natural Sciences > Aging Diseases and Pathology > Cancer & related diseases > Malignant neoplasms (including in situ) > Gastrointestinal cancers > Colorectal cancer
 
Other Information:
Fiscal Year: 1984
Project Start Date: 1 December 1984
Project End Date: 30 November 1996
Administering Institute Or Center: NCI
 
Project Funding Information:
Total Funding: $2,444,675
Year Funding Organization Total Funding, $
1992 NATIONAL CANCER INSTITUTE $2,444,675
Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Project_number Title Year FY Total Cost
There are no results for this project in database.
Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Project number Project title Organization FY Funding Organization FY Total Cost
2R01CA040360-08A1RANDOMIZED TRIAL OF ASPIRIN AND BETA-CAROTENE IN US MDSBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL CANCER INSTITUTE
$2,444,675
5U01HL037852-07COORDINATIONG CENTER - TRIALS OF HYPERTENSION PREVENTIONBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL HEART
$1,413,383
5T32HL007575-08EPIDEMIOLOGY OF CARDIOVASCULAR DISEASEBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL HEART
$149,842
5T32AG000158-05TRAINING PROGRAM IN EPIDEMIOLOGIC RESEARCH ON AGINGBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL INSTITUTE ON AGING
$110,077
5R01HL043851-02TRIAL OF VITAMIN E, BETA-CAROTENE & ASPRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL HEART
$1,170,445
5R01HL042441-03RANDOMIZED TRIAL OF MDS: STUDY OF LOW CV MORTALITYBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL HEART
$384,090
5R01HL034594-08RISK FACTORS FOR CARDIOVASCULAR DISEASE IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL HEART
$186,199
5R01EY008427-03TRIAL OF BETA-CAROTENE AND MACULAR DEGENERATIONBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL EYE INSTITUTE
$145,554
5R01CA047988-02TRIAL OF VITAMIN E, BETA CAROTENE, AND ASPIRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1992NATIONAL CANCER INSTITUTE
$2,218,745
5R01CA040360-09RANDOMIZED TRIAL OF ASPIRIN AND BETA-CAROTENE IN US MDSBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL CANCER INSTITUTE
$2,548,481
5R01HL043851-03TRIAL OF VITAMIN E, BETA-CAROTENE & ASPRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL HEART
$1,393,210
3R01CA047988-03S1VITAMIN E, BETA-CAROTENE, AND ASPIRIN TRIAL IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL CANCER INSTITUTE
$1,070,570
5T32HL007575-09EPIDEMIOLOGY OF CARDIOVASCULAR DISEASEBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL HEART
$159,452
5T32AG000158-06TRAINING PROGRAM IN EPIDEMIOLOGIC RESEARCH ON AGINGBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL INSTITUTE ON AGING
$97,104
5U01HL037852-08COORDINATIONG CENTER - TRIALS OF HYPERTENSION PREVENTIONBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL HEART
$1,425,129
5R01CA047988-03TRIAL OF VITAMIN E, BETA CAROTENE, AND ASPIRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL CANCER INSTITUTE
$2,165,989
2R01HL034594-09RISK FACTORS FOR CARDIOVASCULAR DISEASE IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1993NATIONAL HEART
$191,598
5R01CA040360-10RANDOMIZED TRIAL OF ASPIRIN AND BETA-CAROTENE IN US MDSBRIGHAM AND WOMEN'S HOSPITAL1994NATIONAL CANCER INSTITUTE
$2,733,559
5R01HL043851-04TRIAL OF VITAMIN E, BETA-CAROTENE AND ASPIRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1994NATIONAL HEART
$1,487,741
5R01CA047988-04TRIAL/VITAMIN E BETA CAROTENE & ASPIRIN IN WOMENBRIGHAM AND WOMEN'S HOSPITAL1994NATIONAL CANCER INSTITUTE
$3,668,288
Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Project number Project title Principal investigator
There are no any related projects.
Project Title: Randomized trial of aspirin and beta-carotene in us mds
Principal Investigators (PI): BURING JULIE E
Project Number: 2R01CA040360-08A1
Organization: BRIGHAM AND WOMEN'S HOSPITAL
 
Title Abstract Authors Year Rel