NCT00262561

Brief Summary

263 patients with peripheral atherosclerosis were examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg of clopidogrel 2 h before platelet reactivity analysis. The main hypothesis is that high platelet activity at the beginning of the study is associated with a higher risk of atherothrombosis. Follow up time is 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

December 6, 2005

Last Update Submit

January 25, 2014

Conditions

Intermittent Claudication

Keywords

Intermittent ClaudicationAspirin resistanceClopidogrel resistance

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.

    5 years

Study Arms (1)

Aspirin

ACTIVE COMPARATOR

All participants get Aspirin, and platelet reactivity measurements are performed.

Drug: Aspirin

Interventions

AspirinDRUG

The effect of Aspirin on platelet function was assessed.

Aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atherosclerosis of the lower limbs, defined by one of the following criteria: Ankle-Brachial Pressure Index (ABPI)\< 0.9, intermittent claudication, ischaemic pain at rest, ischaemic ulcers or gangrene.
  • Age \> 18 years
  • For fertile women: Use of safe contraception (intrauterine contraceptive device, the pill, hormonal skin patches, progestogen injections, progestogen implant, vaginal ring)

You may not qualify if:

  • Allergy to either Aspirin or Clopidogrel
  • Known bleeding disorder
  • Platelet count \< 140 mia/L or \> 400 mia/L
  • Intake of NSAID's, SSRI's or Dipyridamol within the preceding 14 days
  • Not radically treated gastrointestinal ulceration within the last 6 month
  • Greater surgical procedures performed within the last 3 month
  • Severe renal disease
  • Severe hepatic disease
  • Breast feeding
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Surgery, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Nils Johannesen, MD

    Department of Vascular Surgery, Aalborg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

DK(1)