Status:
COMPLETED
The Effects of Physical Training, ASA (Aspirin), and Clopidogrel on the Walking Capacity of Patients With Stage II Peripheral Arterial Disease (PAD)
Lead Sponsor:
Arteriogenesis Competence Network
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
45-95 years
Phase:
PHASE4
Brief 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 st...
Detailed Description
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 cereb...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00189618
Start Date
May 1 2005
End Date
June 1 2008
Last Update
October 6 2008
Active Locations (16)
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1
Evangelisches Krankenhaus Hubertus
Berlin, Germany, 14129
2
Dr. Doris Schulte
Berlin, Germany
3
Max Ratschow Klinik Darmstadt
Darmstadt, Germany, 64297
4
University Hospital Dresden
Dresden, Germany, 01307