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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

peripheral vascular diseases - antithrombotics - all type of patients


Related trials

CLIPS, 2007 - aspirin vs placebo

Antonicelli, 1999 - HNF vs placebo

Calabro, 1993 - LMWH vs placebo

Mannarino, 1991 - LMWH vs placebo

Tesi, 1989 - HNF vs placebo

APIC, 1989 - acenocoumarol vs placebo

De Smit, 1987 - phenprocoumon vs placebo



See also:

  • All peripheral vascular diseases clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of acenocoumarol
  •  

    APIC study, 1989

    download pdf: acenocoumarol | antithrombotics for peripheral vascular diseases

    Treatments

    Studied treatment Acenocoumarol INR 2-4.5
    Control treatment Placebo
    Concomittant treatment Pentoxifylline 400 mg pour la moitié des patients (2 ème traitement du plan factoriel). Les patients étaient encouragés à arrêter de fumer, à marcher quotidiennement et à ne mas prendre d’autres traitements sans l’autorisation de leur médecin.
    Treatments description
    dose reçue 2.7 % arrêts pour intolérance pentoxifylline 

    Patients

    Patients AOMI syade II
    Inclusion criteria Patients souffrant de claudication intermittente depuis au plus 12 mois ou dont la maladie s’est aggravée pendant les 12 derniers mois. Ratio pression cheville/bras < 0.90.
    Exclusion criteria Angor d’effort ou autre pathologie interférant avec la capacité à marcher, douleur au repos, ulcères ischémiques ou gangrène, claudication intermittente hautement invalidante, ATCD de chirurgie vasculaire, artérite inflammatoire ou autres causes non-athérosclérotiques de claudication intermittente, besoin d’un traitement avec un anticoagulant, contre-indication à un anticoagulant (hypertension, syndrome hémorragique, ulcère gastroduodénal actif, insuffisance rénale ou hépatique sévère).
    Baseline characteristics
    sexe M 92 % 
    age 60 
    ancienneté des symptômes 9.9 mois 
    HTA 33 % 
    diabète 14 % 
    antécédents CVx 17 % 
    fumeurs nd 
    stades III - IV 0 % 

    Method and design

    Randomized effectives 72 / 74 (studied vs. control)
    Design Factorial plan
    Blinding Simple aveugle
    Follow-up duration 1 an
    Lost to follow-up 5
    Hypothesis supériorité
    Primary endpoint Périmètre de marche
    Withdrawals (T1/T0) 13 / 15


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    All cause death

    2 / 72
    2 / 74
    classic 1,03 [0,15;7,10]

    Fatal MI

    0 / 72
    2 / 74
    classic 0,11 [0,00;7,02]

    Major bleeding

    5 / 72
    0 / 74
    classic 21,58 [0,40;1 177,36]

    Haemmorhagic stroke

    2 / 72
    0 / 74
    classic 9,25 [0,15;569,02]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 2 / 72 (2,8%) 2 / 74 (2,7%) 1,03 [0,15;7,10]
    Fatal MI 0 / 72 (0,7%) 2 / 74 (2,7%) 0,26 [0,01;5,60]
    Major bleeding 5 / 72 (6,9%) 0 / 74 (0,7%) 10,28 [0,57;184,74]
    Haemmorhagic stroke 2 / 72 (2,8%) 0 / 74 (0,7%) 4,11 [0,19;89,63]
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 2,78% 2,70% 0,8‰

    Meta-analysis of all similar trials:

    antithrombotics in peripheral vascular diseases for all type of patients



    Reference(s)

    Trials register # NA
    • Acenocoumarol and pentoxifylline in intermittent claudication. A controlled clinical study. The APIC Study Group.. Dettori AG, Pini M, Moratti A, Paolicelli M, Basevi P, Quintavalla R, Manotti C, Di Lecce C. Angiology 1989 Apr;40:237-48
      Pubmed | Hubmed | Fulltext

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