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The effects of physical training, Aspirin, and Clopidogrel on the walking capacity of patients with stage II peripheral arterial disease

The effects of physical training, Aspirin, and Clopidogrel on the walking capacity of patients with stage II peripheral arterial disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-005041-35-DE
Enrollment
250
Registered
2006-05-30
Start date
2005-10-19
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease, intermittent claudication

Interventions

Product Name: Plavix Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Clopidogrel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75 mg OD- Product Nam

Sponsors

University Hospital Basel, Dept. of Angiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Established diagnosis of PAD Treadmill tested initial claudication distance (ICD) between 50 and 400 meters ICD variability during run-in phase less than 25% History of intermittent claudication longer than 3 months Stabilised treatment of concomitant diseases Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Treatment with oral anticoagulants Surgical vascular reconstruction or catheter based intervention within last 3 months Age less than 45 years (m) and childbearing potential (f) Buerger's disease Peptic ulcer within the previous 6 months History of GI or any other bleeding disorder within the previous 6 months Consuming disease with life expectancy of less than 2 years

Design outcomes

Primary

MeasureTime frame
Main Objective: To test the influence of 2 platelet aggregation inhibitors (Plavix/Aspirin protect) on the walking capacity of patients with intermittent claudication;Secondary Objective: To compare the development of treadmill measured claudication distances with changes in daily life activity;Primary end point(s): Change in initial claudication distance (ICD)

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026