Intracranial EmbolismPhase 2NCT00742612
Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
A Phase 2 study testing ARC1779 Injection in people with Intracranial Embolism and Cerebral Thromboembolism, run by Archemix Corp. at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Embolism, Cerebral Thromboembolism, Carotid Stenosis
- What is being tested?
- ARC1779 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United Kingdom5 sites
Addenbrooke's Hospital, Department of Vascular Surgery
Cambridge, CB2 0QQ
University Hospitals Coventry and Warwickshire NHS TRUST
Coventry, CV2 2DX
Leeds General Infirmary
Leeds, LS1 3EX
St. George's, University of London, Cranmer Terrace
London, SW17 ORE
University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road
Manchester, M23 9LT
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Eddy Scurlock Stroke Center - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
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.
- Being tested
- ARC1779 Injection, Placebo (normal saline)
- Keywords
- Carotid Endarterectomy, von Willebrand Factor, Microembolic Signal
- Medical subject headings
- Intracranial Embolism, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC1779 InjectionDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ARC1779 Injection Receives: Drug: ARC1779 Injection |
| 2 | Placebo comparator | Placebo (normal saline) Receives: Drug: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period
Measured: Immediate Post-Operative Period
To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period.
Measured: Perioperative Period
Secondary outcomes (5)
To determine the effect of ARC1779 on the incidence of new ischemic lesions detectable with diffusion-weighted magnetic resonance imaging (MRI) after carotid endarterectomy
Measured: Up to 7 Days
To determine the general safety and tolerability of ARC1779 Injection in this surgical population
Measured: Up to 7 Days
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD)
Measured: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism
Measured: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and safety parameters.
Measured: Up to 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionApr 2010 (estimated)
Why it stopped: Enrollment slower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Archemix Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St George's, University of London
- Investigators
- Hugh Markus, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742612
- Sponsor's protocol ID
- ARC1779-008
- Status last verified
- Jul 2009
- First submitted
- 25 Aug 2008
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30957581Markus 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.
PubMed 21700934
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT00742612
- Acronym / sponsor ID
- ARC1779-008
- Keywords
- Carotid Endarterectomy, von Willebrand Factor, Microembolic Signal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment slower than expected
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Archemix Corp.Industry (pharma, biotech, devices)
- Collaborators
- St George's, University of London
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (estimated)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ARC1779 InjectionARC1779 Injection |
| 2 | Placebo comparator | Drug: Placebo (normal saline)Placebo (normal saline) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC1779 InjectionStudy 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. | Drug | 1 |
| 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. | Drug | 2 |
Primary outcome
To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period
Time frame: Immediate Post-Operative Period
To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period.
Time frame: Perioperative Period
5 secondary outcomes
To determine the effect of ARC1779 on the incidence of new ischemic lesions detectable with diffusion-weighted magnetic resonance imaging (MRI) after carotid endarterectomy
Time frame: Up to 7 Days
To determine the general safety and tolerability of ARC1779 Injection in this surgical population
Time frame: Up to 7 Days
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD)
Time frame: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism
Time frame: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and safety parameters.
Time frame: Up to 7 Days
Results and safety
The study was stopped early (reason given: Enrollment slower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
- Derived from this study: PubMed 30957581Park 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.
- Derived from this study: PubMed 21700934Markus 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Markus, MD principal investigator
St George's, University of London
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARC1779 Injection in people with Intracranial Embolism and Cerebral Thromboembolism, run by Archemix Corp. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment slower than expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period (time frame: Immediate Post-Operative Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.