Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000826741
Ethics application status
Approved
Date submitted
19/07/2013
Date registered
26/07/2013
Date last updated
8/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of Aspirin versus Ticagrelor in Congestive Heart Failure
Scientific title
Pilot trial of Aspirin versus Ticagrelor in Congestive Heart Failure
Secondary ID [1] 282426 0
nil
Universal Trial Number (UTN)
Trial acronym
PATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart failure patients 289032 0
Heart Failure 289033 0
Condition category
Condition code
Cardiovascular 289371 289371 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomised, double-blind cross-over study of 30 heart failure patients on aspirin. They will have aspirin (oral) stopped for 4 weeks and then be randomised to 2 groups. Group 1 will be aspirin (orally 100mg) and placebo for 6 weeks and then a 4 week no drug and then Ticagrelor (orally) for 6 weeks. Group 2: will be on Ticagrelor for 6 weeks, no drug for 4 weeks, and then aspirin and placebo (bd for 6 weeks. The patients will be followed up for 20 weeks.
Group 1 patients will be treated with aspirin and placebo bd (twice a day) for 6 weeks.Group 2 patients Ticagrelor 90 mg bd for 6 weeks and then cross over.
For monitoring this trial in regards to adherance. The patients will be followed up by the Trial Co-ordinator and Principal Investigator at the followup visits. The drugs will be dispensed by pharmacy at each visit. The patients will be screened and adverse events and compliance will be sought at each visit and and electrolytes and BNP checked at at all visits as well.
Intervention code [1] 287070 0
Treatment: Drugs
Comparator / control treatment
This study will examine the differences in NT-Pro BNP and arterial pressure waveforms between aspirin and Ticagrelor in Heart Failure patients.
The comparator/ control treatment is aspirin plus placebo (placebo will be a sucrose tablet orally) vs just ticagrelor
Control group
Placebo

Outcomes
Primary outcome [1] 289475 0
Primary endpoint is the change fluid loading using biomarker NT-pro B type Natriuretic peptide
Timepoint [1] 289475 0
Difference is afterload using peripheral waveform analysis using tonometry. Both of these endpoints have shown to discriminate between Aspirin and Clopidogrel in heart failure patients. It is anticipated that the difference will be even more marked with Ticagrelor because of the additive prostacyclin mechanism.
At the end of this study we should be able to examine the differences in NT-proBNP between aspirin and ticagrelor patients (12 months duration)
BNP, medical history, vital signs, weight, FBC, UEC's, and arterial studies will be measured at each visit. At baseline, week 4, week 10, week 14, week 20. 5 visits in total.
Primary outcome [2] 289476 0
Aspirin increases pulsatile afterload by enhancing wave reflection in the presence of ace inhibitors -a similiar result is expected of ticagrelor but has not been tested previously. The pulsatile afterload will be recorded using an arterial pressure waveform onto a computer using arterial applanation tonometry. This is a simple non invasive test which is performed with the subject lying down. A small pencil like probe is placed over the artery at the wrist and at the side of the neck. Each recording takes about 5 minutes and is entirely painless and noninvasive.
Timepoint [2] 289476 0
At the end of the study -we should be able to examine the differences of arterial pressure waveforms changes between Aspirin and Ticagrelor in heart failure patients
(Arterial pressure waveforms will be measured at all visits basline, week 4, week 10, week 14 and week 20.) 5 visits in total.
Secondary outcome [1] 303799 0
Measure risk reduction in death and or hospitalization at 12 months. At each scheduled trial visit a medical history will be taken and any adverse events will be documented. A follow up phone call will be carried out at week 24. These patients are routinely followed up in the heart failure clinic at regular intervals as part of their routine care.
Timepoint [1] 303799 0
If results are significant (difference in volume and vascular loading) in this pilot study - a further application for a large scale clinical trial will be completed after 12 months from the baseline. These patients will be followed up in the clinic as part of usual care for heart failure paitents at approximately every 6 weeks or sooner under the the discretion of the treating physician.

Eligibility
Key inclusion criteria
-Men or women age greater than 18 years of age
-on aspirin and ACE inhibitor
-symptomatic heart failure with stable therapy
-Serum pro-BNP greater than 600 pg/mLor NT pro BNP greater than 400 pg/mL and Heart Failure
-ongoing treatment with diuretics
-informed consent
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-aspirin contraindicated or ticagrelor
-Heart failure due to a reversible cause
-ongoing indication to continue aspirin or other antiplatelet therapy
-Atrial fibrillation
-Unstable heart failure or treatment regime
-life limiting systemic illness
-conditions that might interfere with protocol compliance]
-Patients taking NSAID's, clopidogrel, Prasugrel, cyclosporin, or simvastin and ongoing CYP3A4 inhibitors

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)
The drugs will stored and managed in St VIncent's Hospital pharmacy by the Clinical trial pharmacist. After randomisation, initial treatment is according to group 1 (aspirin) or 2 (Ticagrelor). After completion of the first phase the patient is crossed over to the second treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed using an on-line random number generator website (http:www. randomizer.org/form.htm). The generated numbers are placed in consecutive patient envelopes, blinded to investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Patient' s are on usual aspirin, all patients have a 4 week wash out (no aspirin) and are then randomised to group 1 (aspirin plus placebo) or group 2 (ticagrelor) for 6 weeks, then all groups have a 4 week wash out and cross over.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be recorded during the study in Excel spreadsheets for analysis. Analysis will be completed on blinded data, with subsequent unblinding to dtermine the drug effect. 30 patients is what is reasonable to enroll given the time period. 30 patients can provide scientifcally significant results with statistical anaylsis.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
29/07/2013
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1330 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 287648 0
Commercial sector/Industry
Name [1] 287648 0
Astra Zeneca
Country [1] 287648 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Heart Failure Research Trust Fund #869883
Address
Department of Cardiology
Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 286389 0
None
Name [1] 286389 0
Address [1] 286389 0
Country [1] 286389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289617 0
St Vincents Hospital HREC
Ethics committee address [1] 289617 0
Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 289617 0
Australia
Date submitted for ethics approval [1] 289617 0
Approval date [1] 289617 0
29/05/2013
Ethics approval number [1] 289617 0
SVH 12/008

Summary
Brief summary
The purpose of this trial is to investigate whether Aspirin and Ticagrelor have different effects on blood vessel and heart function in the setting of heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39710 0
A/Prof Christopher Hayward
Address 39710 0
Department of Cardiology
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Country 39710 0
Australia
Phone 39710 0
+61403335650
Fax 39710 0
Email 39710 0
[email protected]
Contact person for public queries
Name 39711 0
A/Prof Christopher Hayward
Address 39711 0
St Vincent's Hospital, Sydney
Department of Cardiology
Heart Failure Research,
Darlinghurst, NSW 2010
Country 39711 0
Australia
Phone 39711 0
+61 02 8382111
Fax 39711 0
Email 39711 0
[email protected]
Contact person for scientific queries
Name 39712 0
A/Prof Christopher Hayward
Address 39712 0
St Vincent's Hospital
Department of Cardiology
Heart Failure Research
Victoria Street
Darlinghurst NSW 2010
Country 39712 0
Australia
Phone 39712 0
+61 2 8382 6880
Fax 39712 0
+61 2 8382 6881
Email 39712 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

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