Peripheral Arterial Disease Clinical Trial
Official title:
The Effects of Physical Training, Aspirin, and Clopidogrel on the Walking Capacity of Patients With Stage II Peripheral Arterial Disease
To evaluate the change in walking capacity after a well organized and structured intensive physical training program with supportive pharmacotherapy with Clopidogrel or ASA. It is hypothesized that statistically superior results will emerge from a structured training supported by Clopidogrel as compared to a structured training supported by ASA.
Peripheral arterial disease (PAD) can not be seen in isolation but represents the peripheral
manifestation of a generalized atherosclerosis. The co-morbidity with coronary heart disease
and/or a cerebral atherosclerosis ranges between 20 % and 90 %, depending on the degree of
severity of PAD from 1-5. The relative risk of a (predominantly cardiac) death is increased
by a factor of 2 already in asymptomatic PAD patients; the risk will increase furthermore by
another factor of 2 to 4 when patients become symptomatic. PAD is not a rare disease but has
a prevalence of 15 % to 20 % in an elderly western population (> 50 years of age). While the
clinical presentation of PAD is relatively benign in the majority of cases, the disease
carries a high risk potential with high directly and indirectly related costs. Thus, from a
medical but also from a socio-economic point of view, there is the need to control the PAD
complication rate and related treatment costs as effectively as possible.
The most physiological treatment approach, which is internationally accepted, is physical
training. There is agreement, that physical training does improve the collateralisation of
vascular lesions, does improve the rheologic properties of blood, but does also lead to a
shift from glycolytic (type 2) to oxidative (type 1) muscle fibers in the working
musculature. This shift is associated with an increase in capillary density, a fact which
subsequently favors an optimal oxygen extraction and oxygen utilisation. Another effect of
physical training, which may be of utmost importance, relates to its potential to modify the
patients risk factor profile. It was shown in epidemiological, clinical, and experimental
studies, that even a moderate physical training does increase the insulin receptor
sensitivity (and hence positively influences one of the major factors for atherosclerosis),
does increase the fibrinolytic activity following prothrombotic stimulation, does decrease
the diastolic blood pressure in hypertensive patients, does decrease the LDL/HDL ratio, and
does decrease the overall cardiac mortality.
The aim of any treatment of intermittent claudication is a clinically relevant improvement
in the patient's mobility and quality-of-life. In a previous study it was shown, that a 3
months structured, supervised PAD rehabilitation program will satisfy this demand and will
lead to an improvement of the initial (painfree) claudication distance of approximately
190%. One third of the patients of this study were started on Clopidogrel as a supportive
pharmacotherapy at the beginning of the trial. It was interesting to note that optimal
training results (defined as an improvement of the ICD by > 200 %) were only seen in
patients who were treated with Clopidogrel but were not reported from patients who received
ASA (aspirin) on top of training.
Non-published data from the Art.Net. preclinical group (Dr. I. Höfer, Dr. I. Buschmann,
Freiburg), which were presented at an Art.Net. meeting on March 24, 2003 showed that using a
rabbit hind leg model, the magnitude of GM-CSF and MCP-1 induced arteriogenesis was reduced
by approximately 40 % when ASA was co-administered; in contrast, Clopidogrel when used in
the same model was neutral.
There is broad international agreement that patients with a generalized atherosclerosis and
particularly patients suffering from PAD (who are at high risk for ischemic coronary and/or
cerebral complications) should be treated with an antiaggregant. For pharmacoeconomic
reasons the drug of choice normally is ASA.
However, following Höfer's results, ASA, although effectively preventing thrombotic
complications, may hinder the arteriogenetic process required to normalize the physical
capacity and QoL of PAD patients, a negative ASA effect which is not found with Clopidogrel.
Preliminary data in humans seem to support the hypothesis that in symptomatic stage II PAD
patients Clopidogrel may be superior to ASA, a hypothesis which, in order to become
conclusive, must be confirmed by the results of an evidence level 1 clinical trial.
(Literature at the Centre).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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