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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arteriogenesis Competence Network
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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