Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262561
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2005-12-06
Brief Title:
Resistance to Aspirin andor Clopidogrel Among Patients With PAD
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Prevalence of Resistance to Aspirin andor 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:
None
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?:
None