Effect of cloricromene on intermittent claudication. A randomized, double-blind, placebo-controlled trial in patients treated with aspirin: effect onclaudication distance and quality of life

The main aim of medical treatment for intermittent claudication (IC) is the reduction of mortality and morbidity from ischemic cardiovascular disease. However, symptomatic treatment with the aim of improving exercise performa nce and the overall quality of life may also be an important target of the clinical management of patients with intermittent claudication. Cloricromen e, a drug with antithrombotic and anti-ischemic activities, has previously shown some promising results in patients with claudication. We have carried out a clinical trial to assess. The effect of cloricromene on the claudica tion distance and on the quality of life of patients with IC chronically tr eated with aspirin. A total of 159 patients with IC, Stage II (Fontaine), w ere enrolled in a double-blind, randomized, prospective, multicenter study comparing cloricromene (100 mg orally b.i.d.) or an identical placebo for 6 months. All patients received 160 mg/day aspirin. The primary end-point wa s the improvement of initial claudication distance (ICD) at 6 months as mea sured by a standardized treadmill test. The secondary end-points were the a bsolute claudication distance (ACD) at 6 months, the percentage of patients defined as responders to treatment (improvement of ICD of at least 40%), c hanges in the ischemic window (IW), quality of life as assessed by the SF-3 6 questionnaire, and the occurrence of major cardiovascular events. The ICD increased in both treatment groups, with a non-significant difference at 6 months in favor of cloricromene of +12.3 m. The ACD, percentage of respond ers to treatment and ischemic window also improved in both groups with a sl ight, non-significant trend in favor of cloricromene. Pretreatment quality of life scores showed only a slight worsening compared with an age-matched, healthy population and did not change upon treatment. A post hoc subgroup analysis showed a significant benefit from cloricromene in patients with an ICD at enrollment higher than the median of the patient population. In con clusion, treatment with cloricromene for 6 months does not significantly im prove claudication in patients with Stage II Fontaine peripheral arteriopat hy chronically treated with aspirin. An improvement of 40-60 m in the ICD o n a standardized treadmill test does not translate into a self-perceived im provement in the quality of life as assessed by the SF-36 questionnaire.