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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00742612
Other study ID # ARC1779-008
Secondary ID
Status Terminated
Phase Phase 2
First received August 25, 2008
Last updated February 9, 2010
Start date February 2009
Est. completion date April 2010

Study information

Verified date July 2009
Source Archemix Corp.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date April 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Male or female patients;

- >/= 18 to </= 80 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.

Exclusion Criteria:

- Lack of acoustic window allowing TCD recordings;

- Unable or unwilling to consent;

- Metallic prosthetic cardiac valve;

- Recent (<4 weeks) ischemic stroke involving >1/3 of the MCA territory;

- Any history of hemorrhagic stroke;

- Thrombocytopenia;

- Coagulopathy;

- Trauma or surgery within preceding 30 days;

- History of bleeding disorder, gastrointestinal ulcers, or other medical problem associated with an increased risk of bleeding;

- Use of warfarin and 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 GPIIb/IIIa inhibitor treatment within the preceding 24 hours.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
ARC1779 Injection
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.
Placebo (normal saline)
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.

Locations

Country Name City State
United Kingdom Addenbrooke's Hospital, Department of Vascular Surgery Cambridge
United Kingdom University Hospitals Coventry and Warwickshire NHS TRUST Coventry
United Kingdom Leeds General Infirmary Leeds
United Kingdom St. George's, University of London, Cranmer Terrace London
United Kingdom University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road Manchester
United States Hackensack University Medical Center Hackensack New Jersey
United States Eddy Scurlock Stroke Center - Methodist Hospital Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Archemix Corp. St George's, University of London

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period. Perioperative Period Yes
Secondary 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 No
Secondary To determine the general safety and tolerability of ARC1779 Injection in this surgical population Up to 7 Days Yes
Secondary To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD) Up to 7 Days Yes
Secondary To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism Up to 7 Days Yes
Secondary To assess the relationships among ARC1779 PD, PK, and safety parameters. Up to 7 Days Yes
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