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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01534026




Registration number
NCT01534026
Ethics application status
Date submitted
2/02/2012
Date registered
16/02/2012
Date last updated
1/06/2016

Titles & IDs
Public title
Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
Scientific title
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
Secondary ID [1] 0 0
CP-01/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aspirin
Other interventions - withdrawal of aspirin

Active comparator: Aspirin - Current dose of aspirin for 12 weeks

Experimental: Withdrawal arm - Withdrawal of aspirin for 12 weeks


Treatment: Drugs: Aspirin
Current dose

Other interventions: withdrawal of aspirin
Stopping current dose of aspirin
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in NYHA class
Timepoint [1] 0 0
Week 12 and week 24
Primary outcome [2] 0 0
Change in 6 minute walk test
Timepoint [2] 0 0
12 week and 24 weeks
Primary outcome [3] 0 0
Change in BNP
Timepoint [3] 0 0
12 weeks and 24 weeks
Primary outcome [4] 0 0
change in Quality of Life questionnaire
Timepoint [4] 0 0
12 weeks and 24 weeks

Eligibility
Key inclusion criteria
1. Over the age of 18 years
2. In sinus rhythm at the time of randomisation
3. Have a LVEF <0.40
4. Are receiving ACE inhibitor or ARB, ß-blocker and diuretic therapy at the optimal doses.
5. Has been receiving aspirin therapy for at least 3 months
6. Documented non-ischaemic heart failure. Must have at least 1 of the following:
7. Willing and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ischaemic cardiomyopathy
2. High risk of thromboembolism, including

* atrial fibrillation
* previous thromboembolic event including left ventricular thrombus, stroke or transient ischaemic attack, myocardial infarction, deep venous thrombosis or pulmonary embolus
* an underlying condition which predisposes to thromboembolism e.g. amyloidosis
* idiopathic dilated cardiomyopathy and a history of venous thromboembolism in a first degree relative
3. Systolic BP >160mmHg
4. Uncorrected primary valvular disease
5. Active myocarditis
6. Obstructive or restrictive cardiomyopathy
7. Exercise capacity limited by factors other than cardiac dyspnoea
8. Hospitalisation within one month of randomisation
9. Severe primary pulmonary (VC <1.5L), renal or hepatic disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as a pump to move blood around the body. Aspirin has been traditionally used in heart failure because a tendency towards blood clots (including stroke and heart attack, clots in the legs and in the lungs) has been observed in this group and aspirin's mechanism of action is to prevent blood clots. This is important because two-thirds of cases of heart failure are caused by a blood clot in the coronary artery resulting in a heart attack, and aspirin is given to reduce the chances of further heart attacks.

However aspirin was introduced before clinical trials as the investigators know them now were run. Systematic review of the trials of aspirin in heart failure has shown that its use does not increase survival, and there is no evidence to recommend its routine use. Another important finding was that use of aspirin may reduce the beneficial effects of ACE inhibitors which do have a mortality benefit, and that aspirin was associated with an increase in hospitalisation for heart failure compared to other drugs which prevent clots or placebo.

The investigators propose that the use of aspirin in heart failure that is not caused by heart attacks ("non-ischaemic cardiomyopathy") is unnecessary and could be stopped. The importance of finding evidence to cease unproven medications in heart failure cannot be understated. Patients with heart failure take an average of six prescription medications each day. Each medication has side effects and the interactions of all the drugs together are unknown. Aspirin itself is a drug which frequently has side effects of increased risk of bleeding, gastrointestinal ulceration, as well as kidney impairment.

In this study, the investigators plan to withdraw aspirin from patients with stable non-ischaemic heart failure in a closely monitored environment and watch for the effect of this on heart failure.
Trial website
https://clinicaltrials.gov/study/NCT01534026
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01534026