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RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome

10. februar 2014 oppdatert av: Boehringer Ingelheim

RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1878

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Bouge/Namur, Belgia
        • 1160.67.32008 Boehringer Ingelheim Investigational Site
      • Brasschaat, Belgia
        • 1160.67.32011 Boehringer Ingelheim Investigational Site
      • Edegem, Belgia
        • 1160.67.32005 Boehringer Ingelheim Investigational Site
      • Genk, Belgia
        • 1160.67.32002 Boehringer Ingelheim Investigational Site
      • Gilly, Belgia
        • 1160.67.32006 Boehringer Ingelheim Investigational Site
      • Hasselt, Belgia
        • 1160.67.32003 Boehringer Ingelheim Investigational Site
      • Leuven, Belgia
        • 1160.67.32001 Boehringer Ingelheim Investigational Site
      • Tienen, Belgia
        • 1160.67.32004 Boehringer Ingelheim Investigational Site
  • Bulgaria
      • Bourgas, Bulgaria
        • 1160.67.59007 Boehringer Ingelheim Investigational Site
      • Dimitrovgrad, Bulgaria
        • 1160.67.59009 Boehringer Ingelheim Investigational Site
      • Pleven, Bulgaria
        • 1160.67.59003 Boehringer Ingelheim Investigational Site
      • Pleven, Bulgaria
        • 1160.67.59012 Boehringer Ingelheim Investigational Site
      • Rousse, Bulgaria
        • 1160.67.59006 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59001 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59002 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59004 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59005 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59008 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.67.59010 Boehringer Ingelheim Investigational Site
  • Canada
      • Quebec, Canada
        • 1160.67.11014 Boehringer Ingelheim Investigational Site
    • Alberta
      • Calgary, Alberta, Canada
        • 1160.67.11009 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1160.67.11003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Cambridge, Ontario, Canada
        • 1160.67.11012 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.67.11008 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1160.67.11018 Boehringer Ingelheim Investigational Site
      • Mississauga, Ontario, Canada
        • 1160.67.11017 Boehringer Ingelheim Investigational Site
      • Sudbury, Ontario, Canada
        • 1160.67.11010 Boehringer Ingelheim Investigational Site
      • Sudbury, Ontario, Canada
        • 1160.67.11020 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1160.67.11004 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.67.11016 Boehringer Ingelheim Investigational Site
      • Terrebonne, Quebec, Canada
        • 1160.67.11006 Boehringer Ingelheim Investigational Site
  • Danmark
      • Aarhus C, Danmark
        • 1160.67.45001 Boehringer Ingelheim Investigational Site
      • Hvidovre, Danmark
        • 1160.67.45003 Boehringer Ingelheim Investigational Site
      • Odense, Danmark
        • 1160.67.45002 Boehringer Ingelheim Investigational Site
      • Roskilde, Danmark
        • 1160.67.45004 Boehringer Ingelheim Investigational Site
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
        • 1160.67.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70003 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70004 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70005 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70006 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1160.67.70007 Boehringer Ingelheim Investigational Site
      • Saratov, Den russiske føderasjonen
        • 1160.67.70010 Boehringer Ingelheim Investigational Site
      • Saratov, Den russiske føderasjonen
        • 1160.67.70011 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den russiske føderasjonen
        • 1160.67.70008 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den russiske føderasjonen
        • 1160.67.70009 Boehringer Ingelheim Investigational Site
  • Finland
      • HUS, Finland
        • 1160.67.58001 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 1160.67.58004 Boehringer Ingelheim Investigational Site
      • Kuopio, Finland
        • 1160.67.58003 Boehringer Ingelheim Investigational Site
      • Pori, Finland
        • 1160.67.58002 Boehringer Ingelheim Investigational Site
  • Forente stater
    • Florida
      • Clearwater, Florida, Forente stater
        • 1160.67.10002 Boehringer Ingelheim Investigational Site
  • Frankrike
      • Brest Cedex, Frankrike
        • 1160.67.3305A Boehringer Ingelheim Investigational Site
      • Brest Cedex, Frankrike
        • 1160.67.3305B Boehringer Ingelheim Investigational Site
      • Dijon Cedex, Frankrike
        • 1160.67.3303A Boehringer Ingelheim Investigational Site
      • Dijon Cedex, Frankrike
        • 1160.67.3303B Boehringer Ingelheim Investigational Site
      • Dijon Cedex, Frankrike
        • 1160.67.3303C Boehringer Ingelheim Investigational Site
      • Dijon Cedex, Frankrike
        • 1160.67.3303D Boehringer Ingelheim Investigational Site
      • Paris, Frankrike
        • 1160.67.3301A Boehringer Ingelheim Investigational Site
  • Georgia
      • Tbilisi, Georgia
        • 1160.67.95001 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1160.67.95002 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1160.67.95003 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1160.67.95004 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1160.67.95005 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1160.67.95006 Boehringer Ingelheim Investigational Site
  • India
      • Amedabad, India
        • 1160.67.91004 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1160.67.91001 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1160.67.91005 Boehringer Ingelheim Investigational Site
      • Lucknow, India
        • 1160.67.91007 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1160.67.91002 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.67.91003 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.67.91006 Boehringer Ingelheim Investigational Site
  • Irland
      • Dublin, Irland
        • 1160.67.53001 Boehringer Ingelheim Investigational Site
      • Dublin, Irland
        • 1160.67.53002 Boehringer Ingelheim Investigational Site
  • Italia
      • Ascoli Piceno, Italia
        • 1160.67.39006 Boehringer Ingelheim Investigational Site
      • Milano, Italia
        • 1160.67.39003 Boehringer Ingelheim Investigational Site
      • Milano, Italia
        • 1160.67.39005 Boehringer Ingelheim Investigational Site
      • Parma, Italia
        • 1160.67.39001 Boehringer Ingelheim Investigational Site
      • S. Maria Capua Vetere (CE), Italia
        • 1160.67.39002 Boehringer Ingelheim Investigational Site
      • Torino, Italia
        • 1160.67.39004 Boehringer Ingelheim Investigational Site
  • Korea, Republikken
      • Busan, Korea, Republikken
        • 1160.67.82010 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republikken
        • 1160.67.82008 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republikken
        • 1160.67.82009 Boehringer Ingelheim Investigational Site
      • Daejeon, Korea, Republikken
        • 1160.67.82013 Boehringer Ingelheim Investigational Site
      • Daejoen, Korea, Republikken
        • 1160.67.82006 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republikken
        • 1160.67.82007 Boehringer Ingelheim Investigational Site
      • Jeonju, Korea, Republikken
        • 1160.67.82012 Boehringer Ingelheim Investigational Site
      • Kwang-Ju, Korea, Republikken
        • 1160.67.82005 Boehringer Ingelheim Investigational Site
      • Pusan, Korea, Republikken
        • 1160.67.82011 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1160.67.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1160.67.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1160.67.82003 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1160.67.82004 Boehringer Ingelheim Investigational Site
  • Nederland
      • Amsterdam, Nederland
        • 1160.67.31001 Boehringer Ingelheim Investigational Site
      • Den Bosch, Nederland
        • 1160.67.31003 Boehringer Ingelheim Investigational Site
      • Den Haag, Nederland
        • 1160.67.31007 Boehringer Ingelheim Investigational Site
      • Ede, Nederland
        • 1160.67.31009 Boehringer Ingelheim Investigational Site
      • Groningen, Nederland
        • 1160.67.31002 Boehringer Ingelheim Investigational Site
      • Helmond, Nederland
        • 1160.67.31006 Boehringer Ingelheim Investigational Site
      • Hoogeveen, Nederland
        • 1160.67.31011 Boehringer Ingelheim Investigational Site
      • Rotterdam, Nederland
        • 1160.67.31005 Boehringer Ingelheim Investigational Site
      • Spijkenisse, Nederland
        • 1160.67.31008 Boehringer Ingelheim Investigational Site
      • Tilburg, Nederland
        • 1160.67.31004 Boehringer Ingelheim Investigational Site
  • Norge
      • Drammen, Norge
        • 1160.67.47005 Boehringer Ingelheim Investigational Site
      • Hamar, Norge
        • 1160.67.47002 Boehringer Ingelheim Investigational Site
      • Haugesund, Norge
        • 1160.67.47003 Boehringer Ingelheim Investigational Site
      • Hønefoss, Norge
        • 1160.67.47004 Boehringer Ingelheim Investigational Site
      • Oslo, Norge
        • 1160.67.47001 Boehringer Ingelheim Investigational Site
  • Polen
      • Bydgoszcz, Polen
        • 1160.67.48003 Boehringer Ingelheim Investigational Site
      • Bydgoszcz, Polen
        • 1160.67.48006 Boehringer Ingelheim Investigational Site
      • Gdynia, Polen
        • 1160.67.48004 Boehringer Ingelheim Investigational Site
      • Inowroclaw, Polen
        • 1160.67.48005 Boehringer Ingelheim Investigational Site
      • Sopot, Polen
        • 1160.67.48002 Boehringer Ingelheim Investigational Site
      • Warsaw, Polen
        • 1160.67.48001 Boehringer Ingelheim Investigational Site
  • Romania
      • Baia Mare, Romania
        • 1160.67.40006 Boehringer Ingelheim Investigational Site
      • Braila, Romania
        • 1160.67.40005 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1160.67.40001 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1160.67.40003 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1160.67.40004 Boehringer Ingelheim Investigational Site
      • Oradea, Romania
        • 1160.67.40002 Boehringer Ingelheim Investigational Site
      • Tg. Mures, Romania
        • 1160.67.40007 Boehringer Ingelheim Investigational Site
  • Spania
      • Barcelona, Spania
        • 1160.67.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spania
        • 1160.67.34002 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1160.67.34005 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1160.67.34006 Boehringer Ingelheim Investigational Site
      • Sabadell (Barcelona), Spania
        • 1160.67.34003 Boehringer Ingelheim Investigational Site
      • Tarragona, Spania
        • 1160.67.34004 Boehringer Ingelheim Investigational Site
  • Storbritannia
      • Brighton, Storbritannia
        • 1160.67.44003 Boehringer Ingelheim Investigational Site
      • Exeter, Storbritannia
        • 1160.67.44002 Boehringer Ingelheim Investigational Site
      • Middlesbrough, Storbritannia
        • 1160.67.44001 Boehringer Ingelheim Investigational Site
  • Sverige
      • Göteborg, Sverige
        • 1160.67.46004 Boehringer Ingelheim Investigational Site
      • Göteborg, Sverige
        • 1160.67.46006 Boehringer Ingelheim Investigational Site
      • Malmö, Sverige
        • 1160.67.46007 Boehringer Ingelheim Investigational Site
      • Motala, Sverige
        • 1160.67.46005 Boehringer Ingelheim Investigational Site
      • Stockholm, Sverige
        • 1160.67.46002 Boehringer Ingelheim Investigational Site
      • Uppsala, Sverige
        • 1160.67.46001 Boehringer Ingelheim Investigational Site
      • Vaesteraas, Sverige
        • 1160.67.46003 Boehringer Ingelheim Investigational Site
  • Tsjekkisk Republikk
      • Hradec Kralove, Tsjekkisk Republikk
        • 1160.67.42007 Boehringer Ingelheim Investigational Site
      • Litomerice, Tsjekkisk Republikk
        • 1160.67.42005 Boehringer Ingelheim Investigational Site
      • Ostrava, Tsjekkisk Republikk
        • 1160.67.42008 Boehringer Ingelheim Investigational Site
      • Prague, Tsjekkisk Republikk
        • 1160.67.42001 Boehringer Ingelheim Investigational Site
      • Teplice, Tsjekkisk Republikk
        • 1160.67.42003 Boehringer Ingelheim Investigational Site
      • Zlin, Tsjekkisk Republikk
        • 1160.67.42002 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Berlin, Tyskland
        • 1160.67.49001 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 1160.67.49007 Boehringer Ingelheim Investigational Site
      • Dresden, Tyskland
        • 1160.67.49017 Boehringer Ingelheim Investigational Site
      • Hannover, Tyskland
        • 1160.67.49006 Boehringer Ingelheim Investigational Site
      • Homburg/Saar, Tyskland
        • 1160.67.49019 Boehringer Ingelheim Investigational Site
      • Ludwigshafen am Rhein, Tyskland
        • 1160.67.49008 Boehringer Ingelheim Investigational Site
      • Neuss, Tyskland
        • 1160.67.49015 Boehringer Ingelheim Investigational Site
      • Rostock, Tyskland
        • 1160.67.49004 Boehringer Ingelheim Investigational Site
  • Ukraina
      • Ivano-Frankovsk, Ukraina
        • 1160.67.38002 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraina
        • 1160.67.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraina
        • 1160.67.38007 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraina
        • 1160.67.38001 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraina
        • 1160.67.38003 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraina
        • 1160.67.38005 Boehringer Ingelheim Investigational Site
      • Nikolayev, Ukraina
        • 1160.67.38008 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraina
        • 1160.67.38006 Boehringer Ingelheim Investigational Site
  • Ungarn
      • Budapest, Ungarn
        • 1160.67.36001 Boehringer Ingelheim Investigational Site
      • Budapest, Ungarn
        • 1160.67.36003 Boehringer Ingelheim Investigational Site
      • Budapest, Ungarn
        • 1160.67.36004 Boehringer Ingelheim Investigational Site
      • Debrecen, Ungarn
        • 1160.67.36002 Boehringer Ingelheim Investigational Site
      • Kecskemet, Ungarn
        • 1160.67.36007 Boehringer Ingelheim Investigational Site
      • Komarom, Ungarn
        • 1160.67.36006 Boehringer Ingelheim Investigational Site
      • Miskolc, Ungarn
        • 1160.67.36008 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Ungarn
        • 1160.67.36009 Boehringer Ingelheim Investigational Site
      • Zalaegerszeg, Ungarn
        • 1160.67.36005 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.

Exclusion criteria

  1. Long term treatment with any other oral anticoagulant
  2. Severe/disabling stroke within last 6 months
  3. Conditions associated with increased bleeding risk
  4. Anaemia or thrombocytopenia
  5. Severe renal impairment
  6. Liver disease
  7. Positive pregnancy test

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: placebo
matchet placebo
Legemiddel: placebo
matchet placebo
Eksperimentell: Dabigatran etexilate 50mg
twice daily dosing,
Legemiddel: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Eksperimentell: Dabigatran etexilate 75mg
twice daily dosing, patients with moderate renal impairment allocated 50mg bid
Legemiddel: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Eksperimentell: Dabigatran etexilate 110mg
twice daily dosing, patients with moderate renal impairment allocated 75mg bid
Legemiddel: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Eksperimentell: dabigatran etexilate 150mg
twice daily dosing, patients with moderate renal impairment allocated 110mg bid
Legemiddel: dabigatran etexilate
capsules, twice daily, 26 weeks treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
Tidsramme: 6 month treatment period + 2 week post treatment follow up

International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.

A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.

All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
6 month treatment period + 2 week post treatment follow up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment
Tidsramme: 6 month treatment period + 2 week post treatment follow up
Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment
6 month treatment period + 2 week post treatment follow up
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Tidsramme: 6 month treatment period + 2 week post treatment follow up
Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.
6 month treatment period + 2 week post treatment follow up
Number of Participants With Any Reduction of D-dimer Concentration
Tidsramme: at 1 week and 4 weeks
at 1 week and 4 weeks
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Tidsramme: Baseline and at 1 week and 4 weeks
Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.
Baseline and at 1 week and 4 weeks
Number of Participants With Bleeding Events During Total Observation Time
Tidsramme: 6 month treatment period + 2 week post treatment follow up

International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.

A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.

All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
6 month treatment period + 2 week post treatment follow up
Laboratory Analyses
Tidsramme: 6 month treatment period + 2 week post treatment follow up
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
6 month treatment period + 2 week post treatment follow up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Samarbeidspartnere

Uppsala University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2008

Primær fullføring (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først innsendt

13. februar 2008

Først innsendt som oppfylte QC-kriteriene

21. februar 2008

Først lagt ut (Anslag)

22. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. mars 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1160.67
  • RE-DEEM (Annen identifikator: OTHER)
  • 2007-004301-99 (EudraCT-nummer: EudraCT)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Koronar sykdom

Kliniske studier på placebo

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Israel

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

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