Lægers sundhedsundersøgelse
26. januar 2021 opdateret af: John Michael Gaziano, MD, Brigham and Women's Hospital
At vurdere effekten på kardiovaskulær dødelighed af 325 milligram acetylsalicylsyre på en anden dag og sekundært effekten på kræftforekomsten af et forbrug på 50 milligram betacaroten på en anden dag.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
BAGGRUND:
Trombose spiller en stor rolle i de sene stadier af koronar okklusion. Blodpladeaggregering er en stor komponent i dannelsen af arterielle tromber. I farmakologiske undersøgelser har aspirin vist sig at hæmme blodpladeaggregation og kan derfor forventes at forhindre koronar okklusion. Disse virkninger er tydelige i dosisområdet 100-1000 mg/dag og kan være mest tydelige ved 160 mg dagligt. Højere doser ser ikke ud til at være mere effektive i hverken hæmning af trombocytternes behagelighed eller forlænget blødningstid.
Selvom et tidligt case-kontrolstudie af Jick og Miettinen viste en stor fordel, havde de fleste observationsstudier vist en kardiovaskulær fordel på omkring 20 procent. Konklusive data kunne kun stamme fra et randomiseret forsøg med en stor stikprøvestørrelse.
DESIGN FORTÆLLING:
Randomiseret, dobbeltblind, fast prøve. Deltagerne blev randomiseret i en af fire behandlingsgrupper: en 325 milligram aspirintablet hver anden dag, skiftevis med en 30 milligram kapsel beta-caroten; én aspirin hver anden dag, skiftevis med én kapsel beta-caroten placebo; en aspirin placebotablet hver anden dag, skiftevis med en kapsel beta-caroten; og én aspirin placebotablet hver anden dag, skiftevis med én kapsel beta-caroten placebo. Vigtigste endepunkter for den kardiovaskulære komponent af undersøgelsen var kardiovaskulær dødelighed, total dødelighed og koronare hændelser.
Undersøgelsestype
Interventionel
Fase
- Fase 3
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 84 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Mandlige læger i alderen 40 til 84.
Ingen historie med slagtilfælde, myokardieinfarkt, kræft eller nyresygdom.
Ingen kontraindikationer for aspirin eller beta-caroten.
Ingen aktuel brug af aspirin eller vitamin A-tabeller mere end én gang om ugen.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Buring JE, Hennekens CH. Cost and efficiency in clinical trials: the U.S. Physicians' Health Study. Stat Med. 1990 Jan-Feb;9(1-2):29-33. doi: 10.1002/sim.4780090109.
- Buring JE, Peto R, Hennekens CH. Low-dose aspirin for migraine prophylaxis. JAMA. 1990 Oct 3;264(13):1711-3.
- Ridker PM, Manson JE, Buring JE, Muller JE, Hennekens CH. Circadian variation of acute myocardial infarction and the effect of low-dose aspirin in a randomized trial of physicians. Circulation. 1990 Sep;82(3):897-902. doi: 10.1161/01.cir.82.3.897.
- Manson JE, Grobbee DE, Stampfer MJ, Taylor JO, Goldhaber SZ, Gaziano JM, Ridker PM, Buring JE, Hennekens CH. Aspirin in the primary prevention of angina pectoris in a randomized trial of United States physicians. Am J Med. 1990 Dec;89(6):772-6. doi: 10.1016/0002-9343(90)90220-8.
- Satterfield S, Greco PJ, Goldhaber SZ, Stampfer MJ, Swartz SL, Stein EA, Kaplan L, Hennekens CH. Biochemical markers of compliance in the Physicians' Health Study. Am J Prev Med. 1990 Sep-Oct;6(5):290-4.
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- Ma J, Stampfer MJ, Hennekens CH, Frosst P, Selhub J, Horsford J, Malinow MR, Willett WC, Rozen R. Methylenetetrahydrofolate reductase polymorphism, plasma folate, homocysteine, and risk of myocardial infarction in US physicians. Circulation. 1996 Nov 15;94(10):2410-6. doi: 10.1161/01.cir.94.10.2410.
- Guallar E, Hennekens CH, Sacks FM, Willett WC, Stampfer MJ. A prospective study of plasma fish oil levels and incidence of myocardial infarction in U.S. male physicians. J Am Coll Cardiol. 1995 Feb;25(2):387-94. doi: 10.1016/0735-1097(94)00370-6.
- Ridker PM, Hennekens CH, Lindpaintner K, Stampfer MJ, Eisenberg PR, Miletich JP. Mutation in the gene coding for coagulation factor V and the risk of myocardial infarction, stroke, and venous thrombosis in apparently healthy men. N Engl J Med. 1995 Apr 6;332(14):912-7. doi: 10.1056/NEJM199504063321403.
- Lindpaintner K, Pfeffer MA, Kreutz R, Stampfer MJ, Grodstein F, LaMotte F, Buring J, Hennekens CH. A prospective evaluation of an angiotensin-converting-enzyme gene polymorphism and the risk of ischemic heart disease. N Engl J Med. 1995 Mar 16;332(11):706-11. doi: 10.1056/NEJM199503163321103.
- Ridker PM, Hennekens CH, Cerskus A, Stampfer MJ. Plasma concentration of cross-linked fibrin degradation product (D-dimer) and the risk of future myocardial infarction among apparently healthy men. Circulation. 1994 Nov;90(5):2236-40. doi: 10.1161/01.cir.90.5.2236.
- Newcomer LM, Manson JE, Barbieri RL, Hennekens CH, Stampfer MJ. Dehydroepiandrosterone sulfate and the risk of myocardial infarction in US male physicians: a prospective study. Am J Epidemiol. 1994 Nov 15;140(10):870-5. doi: 10.1093/oxfordjournals.aje.a117175.
- Gann PH, Hennekens CH, Longcope C, Verhoek-Oftedahl W, Grodstein F, Stampfer MJ. A prospective study of plasma hormone levels, nonhormonal factors, and development of benign prostatic hyperplasia. Prostate. 1995 Jan;26(1):40-9. doi: 10.1002/pros.2990260109.
- Gann PH, Hennekens CH, Stampfer MJ. A prospective evaluation of plasma prostate-specific antigen for detection of prostatic cancer. JAMA. 1995 Jan 25;273(4):289-94.
- Buring JE, Hebert P, Romero J, Kittross A, Cook N, Manson J, Peto R, Hennekens C. Migraine and subsequent risk of stroke in the Physicians' Health Study. Arch Neurol. 1995 Feb;52(2):129-34. doi: 10.1001/archneur.1995.00540260031012.
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- Ridker PM, Hennekens CH, Lindpaintner K, Stampfer MJ, Miletich JP. Arterial and venous thrombosis is not associated with the 4G/5G polymorphism in the promoter of the plasminogen activator inhibitor gene in a large cohort of US men. Circulation. 1997 Jan 7;95(1):59-62. doi: 10.1161/01.cir.95.1.59.
- Camargo CA Jr, Stampfer MJ, Glynn RJ, Gaziano JM, Manson JE, Goldhaber SZ, Hennekens CH. Prospective study of moderate alcohol consumption and risk of peripheral arterial disease in US male physicians. Circulation. 1997 Feb 4;95(3):577-80. doi: 10.1161/01.cir.95.3.577.
- Ridker PM, Hennekens CH, Selhub J, Miletich JP, Malinow MR, Stampfer MJ. Interrelation of hyperhomocyst(e)inemia, factor V Leiden, and risk of future venous thromboembolism. Circulation. 1997 Apr 1;95(7):1777-82. doi: 10.1161/01.cir.95.7.1777.
- Albert CM, Hennekens CH, O'Donnell CJ, Ajani UA, Carey VJ, Willett WC, Ruskin JN, Manson JE. Fish consumption and risk of sudden cardiac death. JAMA. 1998 Jan 7;279(1):23-8. doi: 10.1001/jama.279.1.23.
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- Ajani UA, Christen WG, Manson JE, Glynn RJ, Schaumberg D, Buring JE, Hennekens CH. A prospective study of alcohol consumption and the risk of age-related macular degeneration. Ann Epidemiol. 1999 Apr;9(3):172-7. doi: 10.1016/s1047-2797(98)00053-2.
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- Ariyo A, Hennekens CH, Stampfer MJ, Ridker PM. Lipoprotein (a), lipids, aspirin, and risk of myocardial infarction in the Physician's Health Study. J Cardiovasc Risk. 1998 Aug;5(4):273-8.
- Lee IM, Hennekens CH, Berger K, Buring JE, Manson JE. Exercise and risk of stroke in male physicians. Stroke. 1999 Jan;30(1):1-6. doi: 10.1161/01.str.30.1.1.
- Muntwyler J, Hennekens CH, Buring JE, Gaziano JM. Mortality and light to moderate alcohol consumption after myocardial infarction. Lancet. 1998 Dec 12;352(9144):1882-5. doi: 10.1016/S0140-6736(98)06351-X.
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- Ward RE, Orkaby AR, Chen J, Hshieh TT, Driver JA, Gaziano JM, Djousse L. Association between Diet Quality and Frailty Prevalence in the Physicians' Health Study. J Am Geriatr Soc. 2020 Apr;68(4):770-776. doi: 10.1111/jgs.16286. Epub 2019 Dec 16.
- Song Y, Chavarro JE, Cao Y, Qiu W, Mucci L, Sesso HD, Stampfer MJ, Giovannucci E, Pollak M, Liu S, Ma J. Whole milk intake is associated with prostate cancer-specific mortality among U.S. male physicians. J Nutr. 2013 Feb;143(2):189-96. doi: 10.3945/jn.112.168484. Epub 2012 Dec 19.
- Robinson JG, Rahilly-Tierney C, Lawler E, Gaziano JM. Benefits associated with achieving optimal risk factor levels for the primary prevention of cardiovascular disease in older men. J Clin Lipidol. 2012 Jan-Feb;6(1):58-65. doi: 10.1016/j.jacl.2011.10.019. Epub 2011 Nov 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 1981
Primær færdiggørelse (Faktiske)
1. december 1995
Studieafslutning (Faktiske)
1. december 1996
Datoer for studieregistrering
Først indsendt
27. oktober 1999
Først indsendt, der opfyldte QC-kriterier
27. oktober 1999
Først opslået (Skøn)
28. oktober 1999
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Karsygdomme
- Hjertesygdomme
- Myokardieiskæmi
- Koronar sygdom
- Hjerte-kar-sygdomme
- Iskæmi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Beskyttelsesagenter
- Antioxidanter
- Aspirin
- Carotenoider
Andre undersøgelses-id-numre
- 19
- R01HL034595 (U.S. NIH-bevilling/kontrakt)
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Peking University Third HospitalAfsluttet
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Stanford UniversitySuspenderetMyocardial brodannelseForenede Stater
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Izmir Bakircay UniversityAfsluttetMyokardiebro af kranspulsårenKalkun
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Fondazione Policlinico Universitario Agostino Gemelli...Afsluttet
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ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiAfsluttetMyokardiebro af kranspulsårenItalien
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RenJi HospitalAfsluttetSomatisk symptomlidelse | MyokardiebroKina
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Chinese Academy of Medical Sciences, Fuwai HospitalAfsluttetKoronararteriesygdom | Hypertrofisk kardiomyopati | Myocardial brodannelse
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Hospital San Carlos, MadridFundacion Investigacion Interhospitalaria CardiovascularRekrutteringMyokardieiskæmi | Vasospastisk angina | Ikke-obstruktiv koronar aterosklerose | Mikrovaskulær koronararteriesygdom | Myocardial brodannelseSpanien
Kliniske forsøg med aspirin
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Seoul National University HospitalCKD Pharmaceutical LimitedAfsluttet
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The First Affiliated Hospital with Nanjing Medical...UkendtKoronar ateroskleroseKina
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Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryAfsluttetProstatakræftDet Forenede Kongerige
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Seoul National University HospitalAfsluttetSund og raskKorea, Republikken
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University of VigoRekruttering
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Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RekrutteringLungesygdom, kronisk obstruktivForenede Stater
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Assistance Publique - Hôpitaux de ParisRekruttering
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FANG HERekrutteringPræeklampsi | Perinatal blødningKina
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BayerAfsluttetFarmakokinetikForenede Stater
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Boehringer IngelheimAfsluttetKoronar arterioskleroseIrland