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Trial registered on ANZCTR


Registration number
ACTRN12612001157864
Ethics application status
Approved
Date submitted
29/10/2012
Date registered
31/10/2012
Date last updated
5/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the antiplatelet drug Prasugrel on the interactions between immune cells and the blood clotting cells platelets in patients with cardiovascular disease.
Scientific title
The effect of Prasugrel on Platelet – Lymphocyte Interactions
in Vascular disease
Secondary ID [1] 281451 0
Nil
Universal Trial Number (UTN)
U1111-1136-4531
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 287717 0
Condition category
Condition code
Cardiovascular 288051 288051 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised crossover trial and patients with vascular disease and healthy volunteers will receive both Prasugrel and Placebo in oral capsule form. A single loading dose of 60mg of Prasugrel will be given on day 1 and then 10mg per day maintenance for 6 days. Placebo will also be administered for 7 days as a separate drug treatment. There will be a wash out period of 3 weeks between the two treatment periods.
Intervention code [1] 285957 0
Treatment: Drugs
Comparator / control treatment
The placebo treatment phase for both vascular patients and healthy individuals will be an oral microcellulose capsule.

Healthy individuals will receive both the prasugrel and placebo treatments with a wash out of 3 weeks in between treatments
Control group
Placebo

Outcomes
Primary outcome [1] 288260 0
The difference in Interferon gamma production by CD4 T cells as measured by ELISA.
Timepoint [1] 288260 0
Cytokine levels will be measured at baseline, day 7 after first treatment, day 28 after wash out and day 35 after final treatment.
Secondary outcome [1] 299706 0
Change in CD4 T cell phenotype and activation state as measured by flow
cytometry
Timepoint [1] 299706 0
Flow cytometry will be performed at baseline, day 7 after first treatment, day 28 after wash out and day 35 after final treatment.

Eligibility
Key inclusion criteria
Vascular population
Inclusion criteria:
*Patients on carotid surveillance programme with an identified carotid stenosis
of >50%
*Patient is not on any antiplatelet therapy

Healthy population
Inclusion criteria:
*Healthy volunteers aged 18-45
*Not on any cardiovascular medication or immune modulating drugs.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Acute coronary syndrome within the preceding 3 months.
Intercurrent illness
Inability to provide written informed consent.
Compliance with follow-up likely to be inadequate
Known bleeding disorder
Platelet dysfunction
Recent surgery within 3 months
Pregnancy
Allergy to Prasugrel
Administration of antiplatelet agent of NSAIDs in last 2 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from the carotid surveillance programme. This programme
actively follows patients with carotid artery stenosis of 50-69% for 2 years. Currently
there are in excess of 300 patients in this programme and preliminary examination of
this group suggests 20-25% are not on any antiplatelet medication. Study patients
will be invited to participate in the study by a phone call. Healthy volunteers will be
recruited from advertisements around Wellington hospital and Otago Medical School.
Both patients with vascular disease and healthy volunteers will receive Prasugrel and placebo with a 3 week wash out period in between.
Participants will be randomised into either study A or B groups to either receive Prasugrel or Placebo first with a cross over to the other drug in between. The participant and study doctor will not know which group the patient is, a third party will randomise and allocate the drugs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A online random number generator will be used to allocate the patient to group A or B
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4658 0
New Zealand
State/province [1] 4658 0
Wellington

Funding & Sponsors
Funding source category [1] 286224 0
Charities/Societies/Foundations
Name [1] 286224 0
Wellington Medical Research Foundation
Address [1] 286224 0
PO Box 51 211
Wellington 6023
New Zealand
Country [1] 286224 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast District Heath Board
Address
Wellington Regional Hospital
Riddiford Street
Newtown 6021
Wellington
Country
New Zealand
Secondary sponsor category [1] 285034 0
None
Name [1] 285034 0
Address [1] 285034 0
Country [1] 285034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288331 0
Ethics committee address [1] 288331 0
Ethics committee country [1] 288331 0
New Zealand
Date submitted for ethics approval [1] 288331 0
01/11/2012
Approval date [1] 288331 0
21/12/2012
Ethics approval number [1] 288331 0
12CEN59

Summary
Brief summary
The purpose of this research study is to investigate the effects of Prasugrel (a drug
that makes your platelets less sticky) against a placebo (no medication but still a
tablet). We want to see how Prasugrel affects the way the blood clotting cells
platelets, interact with immune cells in the blood. The disease that causes the
narrowing of arteries is driven by immune cells and it could be important to see how
inhibiting platelets affects these immune cells and potentially decrease the narrowing
of arteries
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34885 0
Dr Scott Harding
Address 34885 0
Department of Cardiology
Wellington Hospital
Private Bag 7902
Wellington South 6021

Country 34885 0
New Zealand
Phone 34885 0
+64 4 385 5999
Fax 34885 0
Email 34885 0
scott.harding@ccdhb.org.nz
Contact person for public queries
Name 18132 0
Ms Lisa Johnston
Address 18132 0
Clinical Research Lab
8th floor CSB
Riddiford Street
Wellington Hospital
Newtown 6021
Wellington
Country 18132 0
New Zealand
Phone 18132 0
+64 4 4636559
Fax 18132 0
Email 18132 0
lisa.johnston@vuw.ac.nz
Contact person for scientific queries
Name 9060 0
Ms Lisa Johnston
Address 9060 0
Clinical Research Lab
8th floor CSB
Riddiford Street
Wellington Hospital
Newtown 6021
Wellington
Country 9060 0
New Zealand
Phone 9060 0
+64 4 4636559
Fax 9060 0
Email 9060 0
Lisa.johnston@vuw.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary