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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 moiti� des patients (2 �me traitement du plan factoriel). Les patients �taient encourag�s � arr�ter de fumer, � marcher quotidiennement et � ne mas prendre d�autres traitements sans l�autorisation de leur m�decin.
    Treatments description
    dose re�ue 2.7 % arr�ts pour intol�rance pentoxifylline 

    Patients

    Patients AOMI syade II
    Inclusion criteria Patients souffrant de claudication intermittente depuis au plus 12 mois ou dont la maladie s�est aggrav�e pendant les 12 derniers mois. Ratio pression cheville/bras < 0.90.
    Exclusion criteria Angor d�effort ou autre pathologie interf�rant avec la capacit� � marcher, douleur au repos, ulc�res isch�miques ou gangr�ne, claudication intermittente hautement invalidante, ATCD de chirurgie vasculaire, art�rite inflammatoire ou autres causes non-ath�roscl�rotiques de claudication intermittente, besoin d�un traitement avec un anticoagulant, contre-indication � un anticoagulant (hypertension, syndrome h�morragique, ulc�re gastroduod�nal actif, insuffisance r�nale ou h�patique s�v�re).
    Baseline characteristics
    sexe M 92 % 
    age 60 
    anciennet� des sympt�mes 9.9 mois 
    HTA 33 % 
    diab�te 14 % 
    ant�c�dents 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 sup�riorit�
    Primary endpoint P�rim�tre 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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