[Controlled clinical trial of the effect of aspirin and aspirin + dipyridamole on the development of diabetic retinopathy. I. General protocol. From the DAMAD Study Group (author's transl)].
In diabetic patients platelet abnormalities and hemostatic dysfunction have been reported and may play a role on the development of retinopathy. It has been shown that aspirin and dipyridamole modify platelet functions in vitro and in vivo. The aim of this multicenter controlled clinical trial was to investigate the effect of aspirin and aspirin + dipyridamole on the evolution of background retinopathy. In this paper are described the main clinical characteristics of the 450 patients included in the study, the protocol and the major end-points. Patient recruitment started in 1977 and was completed in 1981. Compliance to the protocol is satisfactory, side effects have been minimal and the number of patients lost to follow up is small.
D000293:Adolescent; D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage*; D001792:Blood Platelets / Q000187:drug effects; D002986:Clinical Trials as Topic; D003930:Diabetic Retinopathy / Q000503:physiopathology / Q000517:prevention & control*; D004176:Dipyridamole / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006487:Hemostasis / Q000187:drug effects; D006801:Humans; D008875:Middle Aged
D004176:Dipyridamole; D001241:Aspirin
Essai contrôlé de l'aspirine et de l'association aspirine + dipyridamole sur l'évolution de la rétinopathie diabétique I. Protocole général. Groupe d'étude damad.