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| Name | Class |
|---|---|
| St George's, University of London | OTHER |
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The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler immediately after surgery. This study will also evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the peri-operative (during surgery) period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ARC1779 Injection |
|
| 2 | Placebo Comparator | Placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC1779 Injection | Drug | Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The ARC1779 treatment group will be dosed to achieve a target ARC1779 steady-state plasma concentration of 3 Ug/mL, using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period | Immediate Post-Operative Period | |
| To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period. | Perioperative Period |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of ARC1779 on the incidence of new ischemic lesions detectable with diffusion-weighted magnetic resonance imaging (MRI) after carotid endarterectomy | Up to 7 Days | |
| To determine the general safety and tolerability of ARC1779 Injection in this surgical population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Markus, MD | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| Eddy Scurlock Stroke Center - Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. | |
| 21700934 | Derived | Markus HS, McCollum C, Imray C, Goulder MA, Gilbert J, King A. The von Willebrand inhibitor ARC1779 reduces cerebral embolization after carotid endarterectomy: a randomized trial. Stroke. 2011 Aug;42(8):2149-53. doi: 10.1161/STROKEAHA.111.616649. Epub 2011 Jun 23. |
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|
| Placebo (normal saline) | Drug | Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The placebo group will be dosed to a steady-state plasma concentration using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min. |
|
| Up to 7 Days |
| To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD) | Up to 7 Days |
| To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism | Up to 7 Days |
| To assess the relationships among ARC1779 PD, PK, and safety parameters. | Up to 7 Days |
| Houston |
| Texas |
| 77030 |
| United States |
| Addenbrooke's Hospital, Department of Vascular Surgery | Cambridge | CB2 0QQ | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS TRUST | Coventry | CV2 2DX | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| St. George's, University of London, Cranmer Terrace | London | SW17 ORE | United Kingdom |
| University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road | Manchester | M23 9LT | United Kingdom |
| ID | Term |
|---|---|
| D020766 | Intracranial Embolism |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D002340 | Carotid Artery Diseases |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C526287 | ARC 1779 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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