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.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 95 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Dr. Doris Schulte | Berlin | |
Germany | Evangelisches Krankenhaus Hubertus | Berlin | |
Germany | Max Ratschow Klinik Darmstadt | Darmstadt | |
Germany | University Hospital Dresden | Dresden | |
Germany | Klinikum Karlsbad-Langensteinbach | Karlsbad | |
Germany | University Hospital Munich | Munich | |
Switzerland | University Hospital Basel Dpt. Angiology | Basel | |
Switzerland | Ospedale San Giovanni | Bellinzona | |
Switzerland | Kantonsspital Bruderholz | Bruderholz | |
Switzerland | Kantonsspital Thurgau | Frauenfeld | |
Switzerland | University Hospital LAusanne | Lausanne | |
Switzerland | Kantonsspital Liestal | Liestal | |
Switzerland | Ospedale La Carita | Locarno | |
Switzerland | Kantonsspital Luzern | Luzern | |
Switzerland | Kantonsspital St. Gallen | St. Gallen | |
Switzerland | University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Arteriogenesis Competence Network |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute claudication distance (ACD) change after prescription (Rx) | 3 Months | No | |
Secondary | Change in daily walking activity, quality of life (QoL), initial claudication distance (ICD) change after Rx | 3 months | No |
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