NCT00189618

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 statistically superior results will emerge from a structured training supported by Clopidogrel as compared to a structured training supported by ASA.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Typical duration for phase_4

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

2.9 years

First QC Date

September 12, 2005

Last Update Submit

October 3, 2008

Conditions

Peripheral Arterial Disease

Keywords

Peripheral vascular diseasePeripheral arterial diseaseWalking CapacityAspirinClopidogrel

Outcome Measures

Primary Outcomes (1)

  • Absolute claudication distance (ACD) change after prescription (Rx)

    3 Months

Secondary Outcomes (1)

  • Change in daily walking activity, quality of life (QoL), initial claudication distance (ICD) change after Rx

    3 months

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Aspirin

2

ACTIVE COMPARATOR
Drug: Clopidogrel

Interventions

AspirinDRUG

100mg p.o. OD

1
ClopidogrelDRUG

75mg p.o. OD

2

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Evangelisches Krankenhaus Hubertus

Berlin, 14129, Germany

Location

Dr. Doris Schulte

Berlin, Germany

Location

Max Ratschow Klinik Darmstadt

Darmstadt, 64297, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Klinikum Karlsbad-Langensteinbach

Karlsbad, 76307, Germany

Location

University Hospital Munich

Munich, 80337, Germany

Location

University Hospital Basel Dpt. Angiology

Basel, 4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, 4101, Switzerland

Location

Kantonsspital Thurgau

Frauenfeld, 8500, Switzerland

Location

University Hospital LAusanne

Lausanne, 1011, Switzerland

Location

Kantonsspital Liestal

Liestal, 4410, Switzerland

Location

Ospedale La Carita

Locarno, 6600, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Singer E, Imfeld S, Staub D, Hoffmann U, Buschmann I, Labs KH, Jaeger KA. Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial. J Am Heart Assoc. 2012 Feb;1(1):51-6. doi: 10.1161/JAHA.111.000067. Epub 2012 Feb 20.

    PMID: 23130118DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular Diseases

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kurt A Jaeger, MD, Prof

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Ulrich Hoffmann, MD, Prof

    University Hospital Munich (LMU)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

DE(6)CH(10)