Platelet Inhibition and Transcranial Doppler (TCD)-Detected Microemboli During and After Carotid Artery Stenting (CAS) in Asymptomatic Patients Prior to Cardiac Surgery

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

As with coronary artery stenting, activation and embolisation of platelets occurs with carotid artery stenting (CAS). Based on promising data on the use of clopidogrel plus aspirin in coronary stenting this dual antiplatelet regimen has been introduced as adjunctive treatment during CAS. There is as yet, however, no randomized controlled trial which compared different loading doses of clopidogrel during CAS. Taking into account that a wide interindividual variability in the response to a loading of clopidogrel exists, this study is intended to establish the optimal loading dose of clopidogrel. Therefore platelet function testing and a 1-hour of postprocedural TCD (transcranial doppler) monitoring will be performed.

Objective: Firstly, to investigate whether the absolute magnitude of Platelet Inhibition inversely correlates with the number of TCD-detected microemboli during and after CAS in patients who are being pre-treated with either a 300 mg or a 600 mg loading dose of clopidogrel. Secondly, if there is any impact on early neurological outcome determined by the loading dose of clopidogrel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R&D Cardiologie
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Ticlopidine

Criteria

Inclusion Criteria:

• patient > 18 years of age

• patient accepted for CAS

• temporal window for TCD available

Exclusion Criteria:

• severe renal impairment (creatinine> 1.5mg/dl), abnormal liver function, malignancy, febrile disorder, acute or chronic inflammatory disease and other diseases influencing platelet reactivity

• extreme tortuositas or calcification of the lesion

• inadequate arterial access

• contraindication for angiography

• patient already receiving clopidogrel

• contra-indication to study drugs

• patients with active bleeding or at high-risk of bleeding

• uncontrolled hypertension ( > 180/110 mmHg) despite optimal medication

• pregnancy and women with inadequate anticonception