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

This study has been completed.
Sponsor:
Information provided by:
Arteriogenesis Competence Network
ClinicalTrials.gov Identifier:
NCT00189618
First received: September 12, 2005
Last updated: October 3, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Drug: Aspirin
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Physical Training, Aspirin, and Clopidogrel on the Walking Capacity of Patients With Stage II Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Arteriogenesis Competence Network:

Primary Outcome Measures:
  • Absolute claudication distance (ACD) change after prescription (Rx) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in daily walking activity, quality of life (QoL), initial claudication distance (ICD) change after Rx [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2005
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Aspirin
100mg p.o. OD
Active Comparator: 2 Drug: Clopidogrel
75mg p.o. OD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189618

Locations
Germany
Dr. Doris Schulte
Berlin, Germany
Evangelisches Krankenhaus Hubertus
Berlin, Germany, 14129
Max Ratschow Klinik Darmstadt
Darmstadt, Germany, 64297
University Hospital Dresden
Dresden, Germany, 01307
Klinikum Karlsbad-Langensteinbach
Karlsbad, Germany, 76307
University Hospital Munich
Munich, Germany, 80337
Switzerland
University Hospital Basel Dpt. Angiology
Basel, Switzerland, 4031
Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Kantonsspital Bruderholz
Bruderholz, Switzerland, 4101
Kantonsspital Thurgau
Frauenfeld, Switzerland, 8500
University Hospital LAusanne
Lausanne, Switzerland, 1011
Kantonsspital Liestal
Liestal, Switzerland, 4410
Ospedale La Carita
Locarno, Switzerland, 6600
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Arteriogenesis Competence Network
Investigators
Principal Investigator: Kurt A Jaeger, MD, Prof University Hospital, Basel, Switzerland
Principal Investigator: Ulrich Hoffmann, MD, Prof University Hospital Munich (LMU)
  More Information

No publications provided

Responsible Party: PD Dr. K.-H. Labs, Arteriogenesis Competence Network
ClinicalTrials.gov Identifier: NCT00189618     History of Changes
Other Study ID Numbers: AN0104
Study First Received: September 12, 2005
Last Updated: October 3, 2008
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Arteriogenesis Competence Network:
Peripheral vascular disease
Peripheral arterial disease
Walking Capacity
Aspirin
Clopidogrel

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014