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Sponsored by: |
Aalborg Hospital |
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Information provided by: | Aalborg Hospital |
ClinicalTrials.gov Identifier: | NCT00262561 |
1000 patients with atherosclerosis of lower limbs are examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A minor group will receive clopidogrel instead of aspirin for 2 weeks.
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 6 years.
Condition | Intervention | Phase |
---|---|---|
Intermittent Claudication |
Drug: Clopidogrel |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prevalence of Resistance to Aspirin and/or Clopidogrel Among Patients With PAD. Prognostic Significance of Resistance to Aspirin |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2006 |
Patients with atherosclerosis of the lower limbs 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 blood clot formation. 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, when described by various laboratory methods. We still do not know which way resistance is best described, and we still do not know if patients who are 'resistant' to either drug are less protected against future heart attacks or strokes.
Main objectives:
Secondary objectives:
Methods:
Platelet activity is measured by the PFA-100 (Dade Behring) and by traditional turbidimetric aggregation.
Patients:
Number needed is 1000.
Follow up:
6 years
Endpoints:
Myocardial infarction, unstable angina, cerebral infarction, transitory cerebral ischaemia, sudden deterioration of symptoms, percutaneous or surgical vascular intervention, amputation, death.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Esben H Madsen, MD | +01-604 221 1536 | ehmadsen@gmail.com |
Contact: Norbert Gehr, MD | +45-99 32 29 79 | aas.u30030@nja.dk |
Denmark | |
Department of Vascular Surgery, Aalborg Hospital | Recruiting |
Aalborg, Denmark, 9000 | |
Contact: Nils Johannesen, MD | |
Contact: Norbert Gehr, MD | |
Principal Investigator: Nils Johannesen, MD |
Principal Investigator: | Nils Johannesen, MD | Department of Vascular Surgery, Aalborg Hospital |
Study ID Numbers: | 2005-003844-68 |
Study First Received: | December 6, 2005 |
Last Updated: | September 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00262561 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: The Danish National Committee on Biomedical Research Ethics |
Intermittent Claudication Aspirin resistance Clopidogrel resistance |
Arterial Occlusive Diseases Signs and Symptoms Aspirin Clopidogrel |
Vascular Diseases Intermittent Claudication Arteriosclerosis |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |