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Effekt af Pexelizumab på dødelighed af alle årsager og myokardieinfarkt hos patienter, der gennemgår koronararterie-bypass-transplantatkirurgi med kardio-pulmonal bypass

21. februar 2017 opdateret af: Alexion Pharmaceuticals

Under en hjerte-bypass-procedure frigives et stof kaldet "komplement" af kroppen. Dette komplement forårsager betændelse, som kan føre til bivirkninger såsom brystsmerter, hjerteanfald, hjertesvigt eller svækkelse af hukommelse, sprog og motorik. Formålet med denne undersøgelse er at finde ud af, om undersøgelseslægemidlet (pexelizumab), som blokerer komplementfrigivelsen, kan reducere sådanne bivirkninger og tages sikkert.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: pexelizumab

Undersøgelsestype

Interventionel

Tilmelding

3000

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - Makenzie Health Science Center
- British Columbia
  - Delta, British Columbia, Canada, B4K 2G5
    - Cathy Metcalfe Research Consultants
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - St. Paul's Hospital
  - Vancouver, British Columbia, Canada, V5Z 1C6
    - Vancouver General Hospital
  - Victoria, British Columbia, Canada, V8R 4R2
    - Victoria Heart Institute
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - University of Manitoba Health Science Centre
  - Winnipeg, Manitoba, Canada, R3E 0Z3
    - Health Science Centre
- New Brunswick
  - St. John, New Brunswick, Canada, E2L 4L2
    - New Brunswick Heart Center
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - General Hospital Health Science Center
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - Dalhousie University
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - McMaster Clinic
  - Toronto, Ontario, Canada, M5G 2C4
    - Toronto General Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook & Women's College Health Science Centre
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Montreal Heart Institute
  - Montreal, Quebec, Canada, H3A 1A1
    - Royal Victoria Hospital
  - Montreal, Quebec, Canada, H2L 4M1
    - University of Montreal
  - Quebec City, Quebec, Canada, G1V 4G5
    - Hopital Laval
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4P 0W5
    - Regina General Hospital
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35211
    - Baptist Medical Center Cardiology
  - Birmingham, Alabama, Forenede Stater, 35249-6880
    - University of Alabama at Birmingham
  - Mobile, Alabama, Forenede Stater, 36604
    - IMC-Diagnostic and Medical Clinic
- Arizona
  - Mesa, Arizona, Forenede Stater, 85202
    - Desert Samaritan - Lutheran Heart
  - Phoenix, Arizona, Forenede Stater, 85006
    - Good Samaritan Regional Medical Center
  - Tucson, Arizona, Forenede Stater, 85724
    - University of Arizona
  - Tucson, Arizona, Forenede Stater, 85712
    - Saguaro Clinical Research
  - Tucson, Arizona, Forenede Stater, 85723
    - Southern Arizona VAMC
- Arkansas
  - Fort Smith, Arkansas, Forenede Stater, 72901
    - Sparks Regional Medical Center
  - Little Rock, Arkansas, Forenede Stater, 72205
    - University of Arkansas
- California
  - Beverly Hills, California, Forenede Stater, 90210
    - Brotman Medical Center
  - Burlingame, California, Forenede Stater, 94401
    - Cardiovascular Associates of the Peninsula
  - Daly City, California, Forenede Stater, 94015
    - Seton Medical Center
  - Fullerton, California, Forenede Stater, 92835
    - St. Jude Medical Center
  - Inglewood, California, Forenede Stater, 90301
    - Apex Cardiology
  - Los Angeles, California, Forenede Stater, 90033
    - University of Southern California
  - Los Angeles, California, Forenede Stater, 90095
    - University of California - Los Angeles
  - Los Angeles, California, Forenede Stater, 90033
    - Huntington Memorial Hospital
  - Los Angeles, California, Forenede Stater, 90057
    - St. Vincent's Hospital
  - Oakland, California, Forenede Stater, 94609-3102
    - Crozer-Chester Medical Center
  - Oceanside, California, Forenede Stater, 92056
    - Tri-City Medical Center
  - Sacramento, California, Forenede Stater, 95819
    - Mercy General Hospital
  - San Diego, California, Forenede Stater, 92123
    - San Diego Cardiac Center
  - San Francisco, California, Forenede Stater, 94115
    - Kaiser Foundation Hospital
  - San Francisco, California, Forenede Stater, 94143
    - UCSF Moffitt-Long Hospital
- Colorado
  - Denver, Colorado, Forenede Stater, 80111
    - South Denver Cardiology Associates
  - Denver, Colorado, Forenede Stater, 80218
    - Western Cardiology Associates
  - Fort Collins, Colorado, Forenede Stater, 80528
    - Heart and Vascular Clinic of Northern CO
- Connecticut
  - Bridgeport, Connecticut, Forenede Stater, 06610
    - Bridgeport Hospital
  - Bridgeport, Connecticut, Forenede Stater, 06606
    - St. Vincent's Medical Center
- Delaware
  - Newark, Delaware, Forenede Stater, 19718
    - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20010
    - Washington Hospital Center
  - Washington, District of Columbia, Forenede Stater, 20007
    - Georgetown University Hospital
  - Washington, District of Columbia, Forenede Stater, 20010
    - Cardiology Associates
  - Washington, District of Columbia, Forenede Stater, 20422
    - VA Medical Center - Washington DC
- Florida
  - Atlantis, Florida, Forenede Stater, 33462
    - Florida Cardiovascular Research
  - Clearwater, Florida, Forenede Stater, 33756
    - Morton Plan Mease Health Care
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Heart Group Research
  - Hudson, Florida, Forenede Stater, 34563
    - Gulf Bay Cardiovascular and Thoracic Associates
  - Jacksonville, Florida, Forenede Stater, 32216
    - Jacksonville Center for Clinical Research
  - Melbourne, Florida, Forenede Stater, 32901
    - MIMA Century Research Associates
  - Merritt Island, Florida, Forenede Stater, 32953
    - Brevard Cardiology Group, PA
  - Miami, Florida, Forenede Stater, 33125
    - Medical Research Unlimited
  - Orlando, Florida, Forenede Stater, 32803
    - Florida Heart Institute at Florida Hospital
  - Orlando, Florida, Forenede Stater, 32806
    - Orlando Heart Center
  - Pensacola, Florida, Forenede Stater, 32504
    - Cardiology Consultants
  - Pensacola, Florida, Forenede Stater, 32514
    - Ford Research Center
  - Sarasota, Florida, Forenede Stater, 34239
    - Sarasota Memorial Hospital
  - St. Petersburg, Florida, Forenede Stater, 33709
    - Northside Hospital ans Heart Institute
  - Tallahassee, Florida, Forenede Stater, 32308
    - Tallahassee Memorial Regional Medical Center
  - Tampa, Florida, Forenede Stater, 33613
    - Pepin Heart and Vascular Institute
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University Hospital
  - Atlanta, Georgia, Forenede Stater, 30342
    - St. Joseph's Hospital
  - Augusta, Georgia, Forenede Stater, 30901
    - University Hospital
  - Decatur, Georgia, Forenede Stater, 30033
    - VA Medical Center- Atlanta
  - Macon, Georgia, Forenede Stater, 31208
    - VA Medical Center - Dubin
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813-3009
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, Forenede Stater, 96819
    - Kaiser Permanente Medical Center
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern University Medical Center
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern Univ. Medical Center
  - Chicago, Illinois, Forenede Stater, 60612
    - University of Illinois - Chicago
  - Evanston, Illinois, Forenede Stater, 60201
    - Evanston Northwestern Healthcare Evanston Hospital
- Indiana
  - Fort Wayne, Indiana, Forenede Stater, 46804
    - Indiana Ohio Heart
  - Indianapolis, Indiana, Forenede Stater, 46219
    - Community Hospital
  - Indianapolis, Indiana, Forenede Stater, 46260
    - St. Vincent's Medical Center
- Iowa
  - Des Moines, Iowa, Forenede Stater, 50314
    - Iowa Heart Center - Laurel
  - Iowa City, Iowa, Forenede Stater, 52242
    - University of Iowa
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160-7378
    - University of Kansas City Medical Center
  - Wichita, Kansas, Forenede Stater, 67214
    - Wesley Medical Center
- Kentucky
  - Louisville, Kentucky, Forenede Stater, 40202
    - University of Louisville
  - Louisville, Kentucky, Forenede Stater, 40292
    - University of Louisville
- Louisiana
  - Houma, Louisiana, Forenede Stater, 70360
    - Cardiovascular Institute of the South
  - New Orleans, Louisiana, Forenede Stater, 70115
    - Turuo Infirmary
  - New Orleans, Louisiana, Forenede Stater, 70118
    - Methodist Hospital
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Alton Ochsner Medical Foundation - Brent House
  - Shreveport, Louisiana, Forenede Stater, 711033
    - Cardiac Centers of Louisiana
  - Thibodaux, Louisiana, Forenede Stater, 70301
    - Cardiovascular Institute of the South
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Forenede Stater, 21218
    - Union Memorial Hospital
  - Takoma Park, Maryland, Forenede Stater, 20912
    - Washington Adventist Hospital
  - Towson, Maryland, Forenede Stater, 21204
    - Midatlantic Cardiovascular Associates
  - Towson, Maryland, Forenede Stater, 21204
    - St. Joseph's Hospital
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, Forenede Stater, 02115
    - Brigham and Womens Hospital
  - Springfield, Massachusetts, Forenede Stater, 01199
    - Baystate Medical Center
  - Worcester, Massachusetts, Forenede Stater, 01655
    - University of Massachusetts
- Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
  - Flint, Michigan, Forenede Stater, 48532
    - McLaren Regional Medical Center
  - Lansing, Michigan, Forenede Stater, 48919
    - Thoracic and Cardiovascular Institute
  - Muskegon, Michigan, Forenede Stater, 46444
    - West Shore Cardiology Research Department
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital
  - Saginaw, Michigan, Forenede Stater, 48602
    - Covenant Medical Center
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - St. Luke's Hospital-Duluth
  - Duluth, Minnesota, Forenede Stater, 55805
    - St. Mary's Duluth Health System
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Abbott Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55416
    - Park Nicollet Medical Center
  - Robbinsdale, Minnesota, Forenede Stater, 55422
    - North Memorial Hospital
  - St. Louis Park, Minnesota, Forenede Stater, 55426
    - Park Nicollet Health Research Center
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 32216
    - Mississippi Center for Clinical Research
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64111
    - St. Luke's Hospital - Mid-America Heart Institute
  - St. Louis, Missouri, Forenede Stater, 63110
    - Washington University School of Medicine
  - St. Louis, Missouri, Forenede Stater, 63110
    - Christian North East Hospital
  - St. Peters, Missouri, Forenede Stater, 63376
    - Cardiology Diagnostics, Ltd.
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Haddon Heights, New Jersey, Forenede Stater, 08035
    - Cardiovascular Associates Of The Delaware Valley
  - Paramus, New Jersey, Forenede Stater, 07652
    - Garden State Cardiology
- New York
  - Bronx, New York, Forenede Stater, 10461
    - Albert Einstein Hospital
  - Brooklyn, New York, Forenede Stater, 11219
    - Maimonides Medical Center
  - Johnson City, New York, Forenede Stater, 13790
    - United Health Services
  - New York City, New York, Forenede Stater, 10021
    - New York Presbyterian Hospital
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester
  - Rochester, New York, Forenede Stater, 14621
    - Rochester General Hospital
  - Valhalla, New York, Forenede Stater, 10595
    - Westchester County Medical Center
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28803
    - Asheville Cardiothoracic Surgeons
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke University Medical Center
  - Winston-Salem, North Carolina, Forenede Stater, 27157
    - West forest School of Medicine
- Ohio
  - Akron, Ohio, Forenede Stater, 44307
    - Akron General Medical Center
  - Akron, Ohio, Forenede Stater, 44309
    - Summa Health Systems
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Good Samaritan Hospital
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Sterling Research Group
  - Cincinnati, Ohio, Forenede Stater, 45220
    - Good Samaritan Hospital -Seton Center
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Tri Health Bethesda North Hospital
  - Cleveland, Ohio, Forenede Stater, 44106
    - University Hopital of Cleveland
  - Columbus, Ohio, Forenede Stater, 43222
    - Mt. Carmel West
  - Dayton, Ohio, Forenede Stater, 45414
    - Dayton Heart Center
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Ohio Heart Center
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - University of Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73112
    - Integris Baptist Medical Center
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma Foundation for Cardiovascular Research
- Oregon
  - Bend, Oregon, Forenede Stater, 97701
    - Bend Memorial Clinic
  - Portland, Oregon, Forenede Stater, 97210
    - Northwest Surgical Associates
  - Portland, Oregon, Forenede Stater, 97232
    - Legacy Good Samaritan Hospital
- Pennsylvania
  - Doylestown, Pennsylvania, Forenede Stater, 18901
    - The Heart Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19102
    - North Memorial Pain Institute
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - University of Pittsburgh Medical Center
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Guthrie Clinical Research
  - West Chester, Pennsylvania, Forenede Stater, 19380
    - Chester County Cardiovascular Center
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater, 37404
    - The Chattanooga Heart Institute Cardiovascular Group, P.C.
  - Memphis, Tennessee, Forenede Stater, 38120
    - Baptist Memorial Hospital
  - Oak Ridge, Tennessee, Forenede Stater, 37830
    - Parkway Cardiovascular Associates
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - Seton Medical Center
  - Austin, Texas, Forenede Stater, 78701
    - Brackenridge Hospital
  - Dallas, Texas, Forenede Stater, 75390
    - University of Texas Southwestern Medical Center
  - Houston, Texas, Forenede Stater, 77030
    - Methodist Hospital
  - Houston, Texas, Forenede Stater, 77030
    - Texas Heart Institute
  - Houston, Texas, Forenede Stater, 77030
    - VA Medical Center - Houston
  - Lubbock, Texas, Forenede Stater, 79430
    - Texas Tech University Health Center
  - San Antonio, Texas, Forenede Stater, 78284
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forenede Stater, 78229
    - South Texas Cardiovascular Consultants Clinical Research Center
  - San Antonio, Texas, Forenede Stater, 78284
    - South Texas VA Health Care
  - Temple, Texas, Forenede Stater, 76508
    - Scott and White Memorial Hospital
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401
    - Fletcher Allen Health Care
- Virginia
  - Arlington, Virginia, Forenede Stater, 22205
    - Cardiovascular and Thoracic Surgery Associates
  - Falls Church, Virginia, Forenede Stater, 22043
    - Inova Fairfax Hospital
  - Fredericksburg, Virginia, Forenede Stater
    - Mary Washington Hospital
  - Norfolk, Virginia, Forenede Stater, 23507
    - Sentara Norfolk General Hospital
  - Roanoke, Virginia, Forenede Stater, 24014
    - Carillion Roanoke Hospital
- Washington
  - Seattle, Washington, Forenede Stater, 98195
    - University of Washington
  - Seattle, Washington, Forenede Stater, 98108
    - VA-Medical Center -Seattle Cardiology
  - Tacoma, Washington, Forenede Stater, 98405
    - Tacoma General Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - FHS Research Center
- West Virginia
  - Charleston, West Virginia, Forenede Stater, 25304
    - Camcare Health Education & Research Institute
- Wisconsin
  - Appleton, Wisconsin, Forenede Stater, 54911
    - Appleton Medical Center
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen-Lutheran Hospital
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Wisconsin Center for Clinical Research
  - Milwaukee, Wisconsin, Forenede Stater, 53295
    - Medical College of Wisconsin
  - Wausau, Wisconsin, Forenede Stater, 54401
    - Cardiovascular Research and Education Foundation, Inc.

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

INKLUSIONSKRITERIER:

Undersøgelsespopulationen vil blive trukket fra patienter, der gennemgår CABG eller CABG plus ventilkirurgi ved hjælp af en bypass-pumpe. Derudover skal de opfylde alle følgende kriterier:

være mindst 18 år gammel;
har en eller flere af følgende risikofaktorer:
diabetes mellitus;
tidligere CABG;
behovet for akut indgreb, defineret i henhold til American College of Cardiology/American Heart Association (ACC/AHA) retningslinjer som værende patienter, der er forpligtet til at blive på hospitalet, men som kan planlægges og opereres inden for en normal planlægningsrutine, ekskl. patienter, der har haft en MI inden for 48 timer efter CABG;
kvinde;
anamnese med en neurologisk hændelse (cerebrovaskulær ulykke, forbigående iskæmisk anfald eller carotis endarterektomi);
historie med kongestiv hjertesvigt (New York Heart Association [NYHA] klasse III eller IV);
anamnese med 2 myokardieinfarkter eller et myokardieinfarkt, der opstod mere end 48 timer, men mindre end fire (4) uger før CABG;
give informeret samtykke.

EXKLUSIONSKRITERIER:

En patient vil ikke være berettiget til studieoptagelse, hvis han/hun opfylder et af følgende eksklusionskriterier:

har planlagt reparation af aortadissektion og/eller kræver rekonstruktion af aortarod;
kræver redningsintervention som defineret af ACC/AHA-retningslinjerne som værende igangværende hjerte-lunge-redning på vej til operationsstuen;
har aktuelt kardiogent shock, akut venstre ventrikelruptur, akut septalruptur eller akut papillær muskelruptur;
har ukontrolleret diabetes, defineret som en dokumenteret plasmablodsukkerværdi > 400 mg/dl (22,2 mmol/L) inden for tre (3) dage før operationen;
har en historie med nyresvigt og en serumkreatininværdi på over 3,0 mg/dl;
har en historie med kronisk leversvigt og/eller levercirrhose;
har en anamnese med malignitet, bortset fra basalcellekarcinom og maligniteter i remission (mere end 2 år);
har enhver aktiv bakteriel eller anden infektion, som er klinisk signifikant, efter investigators mening (f.eks. evaluere evidensen baseret på WBC, temperatur, kulturer osv. som passende for patienten);
har en alvorlig medicinsk tilstand, som efter investigatorens opfattelse sandsynligvis vil ændre patientens helbredelsesforløb eller vurderingen af undersøgelsesmedicinens sikkerhed;
har en historie med alkohol- eller stofmisbrug inden for det seneste år;
har en kendt eller mistænkt arvelig komplementmangel;
har deltaget i ethvert andet afprøvende lægemiddelstudie eller er blevet eksponeret for et forsøgsmiddel eller -udstyr inden for 30 dage efter randomisering;
modtager eller planlægger at modtage ethvert andet forsøgslægemiddel eller -udstyr, eller vil deltage i ethvert andet forskningsstudie under forsøget;
er gravid eller ammer.

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
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alexion Pharmaceuticals

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 (Faktiske)

1. januar 2002

Primær færdiggørelse (Faktiske)

1. marts 2003

Datoer for studieregistrering

Først indsendt

29. oktober 2002

Først indsendt, der opfyldte QC-kriterier

30. oktober 2002

Først opslået (Skøn)

31. oktober 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

CABG

Andre undersøgelses-id-numre

2000099
PRIMO-CABG

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .