Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534026
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
Ingrid Hopper, The Alfred

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Aspirin Other: withdrawal of aspirin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
Study Start Date : March 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Aspirin
Current dose of aspirin for 12 weeks
Drug: Aspirin
Current dose
Experimental: Withdrawal arm
Withdrawal of aspirin for 12 weeks
Other: withdrawal of aspirin
Stopping current dose of aspirin

Primary Outcome Measures :
  1. Change in NYHA class [ Time Frame: Week 12 and week 24 ]
  2. Change in 6 minute walk test [ Time Frame: 12 week and 24 weeks ]
  3. Change in BNP [ Time Frame: 12 weeks and 24 weeks ]
  4. change in Quality of Life questionnaire [ Time Frame: 12 weeks and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, β-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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534026

Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred

Responsible Party: Ingrid Hopper, Dr Ingrid Hopper, The Alfred Identifier: NCT01534026     History of Changes
Other Study ID Numbers: CP-01/12
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors