Th effect of ARC1779 on Cerebral Microembolism

• Research type

  Research Study

• Full title

  The Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

• IRAS ID

  6915

• Sponsor organisation

  Archemix Corp

• Eudract number

  2008-005246-23

• ISRCTN Number

  N/A

• Research summary

  This study is evaluating a new drug designed to prevent cerebral embolism and stroke. Embolism (where a blood clot forms in the body and passes to a blood vessel in the brain and blocks it) is a major cause of stroke. Drugs which inhibit platelets (blood particles) have been shown to reduce embolism but only prevent a proportion of cases. This study will evaluate a new type of anti-platelet drug which inhibits Von Willebrand Factor (VWF). The drug, ARC1779, has been developed by a company Archemix Corp.In this first study in patients at risk of stroke in man we will evaluate the effectiveness of the drug using a technique which allows us to monitor asymptomatic emboli as they pass through the blood vessels in the brain. We will study patients who are under going an operation to remove a narrowing in the artery in the neck (carotid endarterectomy). Following this operation small clots form at the site of operation and produce emboli which pass into the brain blood vessels. These can be monitored using an ultrasound technique called Trans-cranial Doppler.For the 100 patients we randomise to receive either ARC1779 or placebo. We will see whether ARC1779 is associated with less emboli detected using this ultrasound technique in the immediate postoperative period. We will also study the safety profile of ARC1779 and determine whether there is increased bleeding in the actively treated group compared with the placebo group.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/149

• Date of REC Opinion

  17 Dec 2008

• REC opinion

  Further Information Favourable Opinion