ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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Go to the Login page, click ‘reset password’ and follow the instructions.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12606000358549

Ethics application status

Not yet submitted

Date submitted

18/04/2006

Date registered

18/08/2006

Date last updated

18/08/2006

Type of registration

Retrospectively registered

Titles & IDs

Public title

Impact of Glycopyrrolate on Carotid Angioplasty and Stenting

Scientific title

Prophylactic glycopyrrolate vs placebo in carotid angioplasty and stenting for carotid stenosis to prevent bradycardia and/or hypotension and improve post-operative outcome.

Universal Trial Number (UTN)

Trial acronym

GCAS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Carotid angioplasty and stenting for carotid stenosis

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Glycopyrrolate
1. Dosage of drug: Glycopyrrolate 0.2-0.4mg
Frequency: Once only at not less than 6 mins before balloon inflation but not more than 2 hours before balloon inflation
Mode: intravenous
2. Intervention group: Receives glycopyrrolate
3. Control group: Receives normal saline (placebo)
4. Duration of intervention: Once only administration of glycopyrrolate given as detailed above.

Intervention code [1]

Prevention

Comparator / control treatment

Placebo

Control group

Placebo

Outcomes

Primary outcome [1]

Reduction in intra-operative bradycardia and/or hypotension

Timepoint [1]

Intra-operative

Secondary outcome [1]

Reduction in post-operative cardiovascular and neurological morbidity and mortality.

Timepoint [1]

Post-operative till discharge (usually 3 days).

Eligibility

Key inclusion criteria

All patients for carotid angioplasty and stenting.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Inability to consent, patient refusal, allergy to glycopyrrolate.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Non-participating anaesthetist will draw up glycopyrrolate or placebo and give it to be administered by the participating anaesthetist.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation via computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Dept. of Anaesthesia, St. Vincent’s Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Crispin Wan

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Assoc. Prof. Michael Davies

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St. Vincent's Hospital, Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Aims: Certain patients have a narrowing in the blood vessel that supplies blood to the brain.  If this blood vessel gets blocked these patients can suffer a stroke because there is no blood flow to that part of the brain.  One method of keeping this blood vessel open is a procedure where a special line is inserted into the blood vessel and a balloon is inflated.  Inflating the balloon will cause the blood vessel to get bigger.  To make sure that the blood vessel stays open a device called a stent (like a rigid internal pipe) is placed as well.  This procedure is called carotid angioplasty and stenting.  However, making the blood vessel bigger in this way can activate a nerve which can act on the heart, which can cause the heart rate and blood pressure to change significantly.  
Glycopyrrolate is a drug which is commonly used to increase a patient’s heart rate.  In this  study, glycopyrrolate, is given before the balloon is inflated to try to prevent the changes in heart rate and blood pressure.  The aims of the study are to see if giving glycopyrrolate can prevent the changes in heart rate and blood pressure as well as improving the outcome of the patient after the procedure.  
Methodology: Information will be collected on the patient’s medical problems before the procedure.  Patients will then be randomised to receive either an injection of glycopyrrolate or water before balloon inflation.  Complications during the procedure will be noted such as changes in heart rate, blood pressure and electrocardiograph changes.  If the patient does develop changes in heart rate or blood pressure, rescue medications will be available.  After the procedure, cardiovascular and neurological complications will be noted.  
Blinding: Double blind: Non-participating anaesthetist will open a sealed opaque envelope and draw up either glycopyrrolate or water (to an equal volume) and give it to the participating anaesthetist to administer.  Neither the patient or the participating anaesthetist will know if the drug is glycopyrrolate or placebo.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Crispin Wan

Address

Department of Anaesthesia St. Vincent’s Hospital PO Box 2900 Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92882211

Fax

[email protected]

Contact person for scientific queries

Name

Dr Crispin Wan

Address

Department of Anaesthesia St. Vincent’s Hospital PO Box 2900 Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92882211

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically