Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
Study NCT ID:
NCT00262561
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2005-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
Prevalence of Resistance to Aspirin and/or Clopidogrel Among Patients With PAD. Prognostic Significance of Resistance to Aspirin
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: