Patients undergoing carotid endarterectomy, MedDRA version: 9.1 Level: LLT Classification code 10007692 Term: Carotid endarterectomy
Conditions
Interventions
Product Name: ARC1779
Product Code: ARC1779
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous u
Sponsors
Archemix Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria • Male or female patients; • 18 to 85 years of age; • Carotid stenosis (either symptomatic or asymptomatic); • Planned carotid endarterectomy; • Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment; • Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment; • All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Lack of acoustic window allowing TCD recordings; • Unable or unwilling to consent; • Medical condition unsuitable for planned carotid endarterectomy surgery; • Metallic prosthetic cardiac valve; • Recent (1/3 of the middle cerebral artery (MCA) territory; • Any history of hemorrhagic stroke; • Thrombocytopenia; • Coagulopathy; • Recent or current bleeding disorder or other medical problem associated with an increased risk of bleeding; • Trauma or surgery within preceding 30 days; • Use of warfarin or any chronic antithrombotic therapy other than acetylsalicylic acid and/or dipyridamole; patients previously treated with warfarin are eligible if the drug has been discontinued and the INR prior to randomization has returned to <1.3; • Use of clopidogrel, unless it has been discontinued at least 5 days prior to randomization; • Fibrinolytic or glycoprotein (GP) IIb/IIIa inhibitor treatment within the preceding 24 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives • To determine the effect of a continuous intravenous infusion of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period; • To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period.;Secondary Objective: Secondary Objectives • To determine the effect of ARC1779 on the incidence of new ischemic lesions detectable with diffusion-weighted magnetic resonance imaging (MRI) after carotid endarterectomy; • To determine the general safety and tolerability of ARC1779 Injection in this surgical population; • To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD); • To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism; • To assess the relationships among ARC1779 PD, PK, and safety parameters.;Primary end point(s): Primary Efficacy Variable • Number of microembolic signals (MES) detected by TCD during the 3 hours immediately following restoration of carotid circulation. Secondary Efficacy Variables • Hourly number of MES during each of the 3 hours of postoperative recording; • Proportion of patients without MES overall, and in each of the 3 hours of postoperative recording; • Kaplan-Meier analysis of freedom from MES; • Mean intensity of embolic signals in patients with MES; • Proportion of patients with >10 MES per hour; • Group mean number of new lesions on postoperative MRI by diffusion-weighted imaging (DWI); • Proportion of patients with new postoperative DWI lesions; • Clinical transient ischemic attack (TIA) and stroke during the first postoperative week; • Group mean concentration of a biomarker for central nervous system (CNS) injury (S100 ). | — |
Countries
United Kingdom
Outcome results
None listed