Heart FailurePhase 4NCT01534026
Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
A Phase 4 study testing Aspirin and withdrawal of aspirin in people with Heart Failure, run by The Alfred at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aspirin and withdrawal of aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- Aspirin, withdrawal of aspirin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Current dose
withdrawal of aspirinOther
Stopping current dose of aspirin
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Current dose of aspirin for 12 weeks Receives: Drug: Aspirin |
| Withdrawal arm | Experimental | Withdrawal of aspirin for 12 weeks Receives: Other: withdrawal of aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA class
Measured: Week 12 and week 24
Change in 6 minute walk test
Measured: 12 week and 24 weeks
Change in BNP
Measured: 12 weeks and 24 weeks
change in Quality of Life questionnaire
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Hopper, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534026
- Sponsor's protocol ID
- CP-01/12
- Status last verified
- May 2016
- First submitted
- 2 Feb 2012
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
- ClinicalTrials.gov ID
- NCT01534026
- Acronym / sponsor ID
- CP-01/12
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinCurrent dose of aspirin for 12 weeks |
| Withdrawal arm | Experimental | Other: withdrawal of aspirinWithdrawal of aspirin for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- Ischaemic cardiomyopathy
- High risk of thromboembolism, including
- Systolic BP >160mmHg
- Uncorrected primary valvular disease
- Active myocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinCurrent dose | Drug | Aspirin |
| withdrawal of aspirinStopping current dose of aspirin | Other | Withdrawal arm |
Primary outcome
Change in NYHA class
Time frame: Week 12 and week 24
Change in 6 minute walk test
Time frame: 12 week and 24 weeks
Change in BNP
Time frame: 12 weeks and 24 weeks
change in Quality of Life questionnaire
Time frame: 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and withdrawal of aspirin in people with Heart Failure, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NYHA class (time frame: Week 12 and week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.