Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00262561
Study type Interventional
Source Aalborg Universitetshospital
Contact
Status Completed
Phase Phase 4
Start date January 2006
Completion date January 2008

See also
  Status Clinical Trial Phase
Recruiting NCT05400395 - Clinical Trial for GNX80 in Intermittent Claudication Phase 4
Active, not recruiting NCT02341716 - Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication N/A
Completed NCT02041169 - Lower Extremity Peripheral Arterial Disease and Exercise Ischemia N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Recruiting NCT00538408 - Whole Body Magnetic Resonance Angiography in Ischemic Patients N/A
Completed NCT00388128 - Caffeine and Intermittent Claudication Phase 3
Completed NCT00618670 - Home-based vs. Supervised Exercise for People With Claudication N/A
Recruiting NCT00146666 - Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD) Phase 2
Completed NCT00134277 - Trial Comparing Different Medical Devices for Infragenual Dilatation N/A
Completed NCT01256775 - Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD) Phase 2
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Recruiting NCT06299956 - Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark N/A
Not yet recruiting NCT05335161 - A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease Phase 1
Completed NCT04390282 - Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication N/A
Completed NCT03271710 - Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System N/A
Completed NCT02380794 - Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule Phase 2
Active, not recruiting NCT02276937 - Randomized Phase IIb Trial of DVC1-0101 Phase 2
Completed NCT02097082 - Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00071266 - The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Phase 3