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Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intermittent Claudication focused on measuring Intermittent Claudication, Aspirin resistance, Clopidogrel resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Department of Vascular Surgery, Aalborg Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Aspirin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2005
Last Updated
January 25, 2014
Sponsor
Aalborg University Hospital
Collaborators
Danish Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00262561
Brief Title
Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.
Official Title
Prevalence of Resistance to Aspirin and/or Clopidogrel Among Patients With PAD. Prognostic Significance of Resistance to Aspirin
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Danish Heart Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients with peripheral atherosclerosis are at high risk of atherothrombosis, mainly heart attack and stroke. The medical treatment of these patients include platelet inhibiting drugs, usually aspirin, to reduce the risk of ischemic events. Clopidogrel is another platelet inhibiting drug, which is prescribed less often, primarily because of the high costs compared to aspirin. Phenomena of 'resistance' to these drugs have been described by numerous investigators. Essentially resistance means that the effect of the drug described is less than expected or missing, as measured by various laboratory methods. We do not know which way resistance is best described, but it has been described that patients who are 'resistant' to either drug are less protected against future heart attacks or strokes. Main objectives: To measure the activity of platelets in these patients during aspirin treatment. To measure the activity of platelets in a minor population of these patients during clopidogrel treatment. To evaluate the prognostic significance of resistance to aspirin in these patients. Methods: Platelet activity is measured by the PFA-100 (Dade Behring) and by traditional turbidimetric aggregation. Endpoints: Myocardial infarction, unstable angina, cerebral infarction, transitory cerebral ischaemia, sudden deterioration of symptoms, percutaneous or surgical vascular intervention, amputation, death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Intermittent Claudication, Aspirin resistance, Clopidogrel resistance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
All participants get Aspirin, and platelet reactivity measurements are performed.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
The effect of Aspirin on platelet function was assessed.
Primary Outcome Measure Information:
Title
Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Johannesen, MD
Organizational Affiliation
Department of Vascular Surgery, Aalborg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular Surgery, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.

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