The Effects of Physical Training, ASA (Aspirin), and Clopidogrel on the Walking Capacity of Patients With Stage II Peripheral Arterial Disease (PAD)

Inclusion Criteria:

1. Inclusion criteria for CD stability testing:

   • Patients of both sexes with subjectively reported initial claudication distances between 50 and 500 m
   • Patients with treadmill tested initial claudication distances between 50 and 400 m
   • History of intermittent claudication > 3 months
   • Established PAD diagnosis (ABI reference leg < 0.95 in non-diabetics, TBI reference leg < 0.70 in diabetics)
   • CLI ruled-out (ankle pressures > 50 mmHg (non diabetics), toe pressures > 30 mmHg (diabetics))
   • Stabilized treatment of concomitant diseases

2. Inclusion criteria for randomized treatment phase:

   • Patients of both sexes with treadmill tested initial claudication distances between 50 and 400 m
   • ICD variability during stability testing phase less than 25 %
   • History of intermittent claudication > 3 months
   • Established PAD diagnosis (ABI reference leg < 0.95 in non-diabetics, TBI reference leg < 0.70 in diabetics)
   • CLI ruled-out (ankle pressures > 50 mmHg (non diabetics), toe pressures > 30 mmHg (diabetics))
   • Stabilized treatment of concomitant diseases
   • Written informed consent

Exclusion Criteria:

• Treatment with oral anticoagulants (except those cases, where the parallel treatment with a platelet aggregation inhibitor (ASA, Clopidogrel) and an oral anticoagulant is medically indicated and justified)
• Lower extremity surgical reconstruction or PTA within the last 3 months
• Age < 45 years old (M), childbearing potential (F)
• Buerger's disease
• Clinically evident peripheral polyneuropathy (sensibility to vibration < 4/8, ATR not revocable)
• Presence of orthopedic, cardiac, pulmonary, or other concomitant diseases interfering with or preventing steady walking on a treadmill
• Clinically manifested congestive cardiac failure (NYHA class II - IV)
• Pretreatment with vasotherapeutics within the last 4 weeks prior to recruitment to the study without appropriate wash-out (> 5 half life times of the vasoactive drug)
• Consuming disease with life expectancy of less than 2 years
• Noncompliance of patient due to personality disorders or concomitant disease
• Known ASA or Clopidogrel intolerance
• Conditions requiring the regular intake of non-steroidal anti-inflammatory drugs
• Peptic ulcer within the previous 6 months
• History of GI or any other bleeding disorder within the previous 6 months