Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
1 other identifier
interventional
12
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started Mar 2012
Typical duration for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 16, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJune 1, 2016
May 1, 2016
2.9 years
February 2, 2012
May 30, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Change in NYHA class
Week 12 and week 24
Change in 6 minute walk test
12 week and 24 weeks
Change in BNP
12 weeks and 24 weeks
change in Quality of Life questionnaire
12 weeks and 24 weeks
Study Arms (2)
Aspirin
ACTIVE COMPARATORCurrent dose of aspirin for 12 weeks
Withdrawal arm
EXPERIMENTALWithdrawal of aspirin for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Over the age of 18 years
- In sinus rhythm at the time of randomisation
- Have a LVEF \<0.40
- Are receiving ACE inhibitor or ARB, β-blocker and diuretic therapy at the optimal doses.
- Has been receiving aspirin therapy for at least 3 months
- Documented non-ischaemic heart failure. Must have at least 1 of the following:
- Willing and able to provide informed consent
You may not qualify if:
- Ischaemic cardiomyopathy
- 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
- Systolic BP \>160mmHg
- Uncorrected primary valvular disease
- Active myocarditis
- Obstructive or restrictive cardiomyopathy
- Exercise capacity limited by factors other than cardiac dyspnoea
- Hospitalisation within one month of randomisation
- Severe primary pulmonary (VC \<1.5L), renal or hepatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Alfredlead
Study Sites (1)
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Ingrid Hopper
Study Record Dates
First Submitted
February 2, 2012
First Posted
February 16, 2012
Study Start
March 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 1, 2016
Record last verified: 2016-05