See also:
All peripheral vascular diseases clinical trials
All clinical trials of antithrombotics
All clinical trials of acenocoumarol
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Treatments
Studied treatment |
Acenocoumarol INR 2-4.5
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Control treatment |
Placebo
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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 |
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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 % |
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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] |
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|
Fatal MI
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0 / 72 (0,7%) |
2 / 74 (2,7%) |
0,26 |
[0,01;5,60] |
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|
Major bleeding
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5 / 72 (6,9%) |
0 / 74 (0,7%) |
10,28 |
[0,57;184,74] |
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|
Haemmorhagic stroke
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2 / 72 (2,8%) |
0 / 74 (0,7%) |
4,11 |
[0,19;89,63] |
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The primary endpoint (if exists) appears in blod characters
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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‰
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Meta-analysis of all similar trials:
antithrombotics in peripheral vascular diseases for all type of patients
Reference(s)
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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
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Hubmed
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