Trial Review

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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 1327 0
Condition category
Condition code
Cardiovascular 1415 1415 0 0
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] 987 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1936 0
Reduction in intra-operative bradycardia and/or hypotension
Timepoint [1] 1936 0
Intra-operative
Secondary outcome [1] 3396 0
Reduction in post-operative cardiovascular and neurological morbidity and mortality.
Timepoint [1] 3396 0
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?
No
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
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1547 0
Hospital
Name [1] 1547 0
Dept. of Anaesthesia, St. Vincent’s Hospital
Country [1] 1547 0
Australia
Primary sponsor type
Individual
Name
Dr Crispin Wan
Address
Country
Secondary sponsor category [1] 1360 0
Individual
Name [1] 1360 0
Assoc. Prof. Michael Davies
Address [1] 1360 0
Country [1] 1360 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2976 0
St. Vincent's Hospital, Melbourne
Ethics committee address [1] 2976 0
Ethics committee country [1] 2976 0
Australia
Date submitted for ethics approval [1] 2976 0
Approval date [1] 2976 0
Ethics approval number [1] 2976 0

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 35183 0
Address 35183 0
Country 35183 0
Phone 35183 0
Fax 35183 0
Email 35183 0
Contact person for public queries
Name 10176 0
Dr Crispin Wan
Address 10176 0
Department of Anaesthesia
St. Vincent’s Hospital
PO Box 2900
Fitzroy VIC 3065
Country 10176 0
Australia
Phone 10176 0
+61 3 92882211
Fax 10176 0
Email 10176 0
[email protected]
Contact person for scientific queries
Name 1104 0
Dr Crispin Wan
Address 1104 0
Department of Anaesthesia
St. Vincent’s Hospital
PO Box 2900
Fitzroy VIC 3065
Country 1104 0
Australia
Phone 1104 0
+61 3 92882211
Fax 1104 0
Email 1104 0
[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
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Documents added automatically
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