Aspirin to Target Arterial Events in Chronic Kidney Disease (ATTACK)
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|ClinicalTrials.gov Identifier: NCT03796156|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : June 4, 2019
This study aims to find out whether people with chronic kidney disease [CKD] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease [CVD]). CKD is common and is associated with an increased risk of CVD.
CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding.
Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks.
Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Cardiovascular Diseases Bleeding||Drug: Aspirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Adjudication of outcomes blinded|
|Official Title:||Aspirin to Target Arterial Events in Chronic Kidney Disease|
|Actual Study Start Date :||February 25, 2019|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
75mg of non enteric coated aspirin once daily added to usual medications
75mg low dose non enteric coated
No Intervention: Usual care
Usual medications only
- Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage) [ Time Frame: Over average 4 years follow-up ]
Acute MI defined according to the Third Universal Definition of myocardial infarction (MI).
Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke (fatal and non-fatal) including intracerebral haemorrhage and SAH which has been confirmed on appropriate imaging is excluded from the primary composite endpoint and included within the secondary endpoints.
- Number of participants dying from any cause [ Time Frame: Average 4 years follow-up ]Death from any cause
- Number of participants with major vascular events plus revascularisation [ Time Frame: Average 4 years follow-up ]Primary outcome plus coronary and non coronary arterial revascularisation. It will include open and percutaneous coronary and non-coronary (including carotid, aortic and limb) procedures (as defined in Office of Population Censuses and Surveys OPCS-4 procedure codes) and will be ascertained from Hospital Episode Statistics (HES) data.
- Number of participants with Non-fatal myocardial infarction [ Time Frame: Average 4 years follow-up ]Non-fatal myocardial infarction. Acute MI defined according to the Third Universal Definition of myocardial infarction (MI).
- Health-related quality of life, mean utility score [ Time Frame: Average 4 years follow-up ]Euroqol EQ-5D utility score derived from 5 states (scoring 1-5) converted to utility values using UK general population set
- Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage [ Time Frame: Average 4 years follow-up ]
Intra-cranial haemorrhage includes intracerebral haemorrhage, subarachnoid haemorrhage, subdural haemorrhage, and extradural haemorrhage.
Extra-cranial haemorrhage is:
- Fatal bleeding, or
- Symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, or
- Bleeding that leads to the transfusion of two or more units of whole blood or red cells
In particular, to be classified as major, bleeds in a critical area or organ should:
- Be associated with a symptomatic clinical presentation (not following an incidental finding)
- Be the cause of the symptoms
- Number of participants with Fatal and non-fatal intra-cranial haemorrhage [ Time Frame: Average 4 years follow-up ]Fatal and non-fatal intra-cranial haemorrhage as above
- Number of participants with Fatal and non-fatal major extra-cranial haemorrhage [ Time Frame: Average 4 years follow-up ]Fatal and non-fatal major extra-cranial haemorrhage as above
- Number of participants with Clinically relevant non major bleeding [ Time Frame: Average 4 years follow-up ]
Defined in accordance with the International Society on Thrombosis and Haemostasis (ISTH) as any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
- Requiring medical intervention by a healthcare professional
- Leading to hospitalisation or increased level of care
- Prompting a face to face (i.e. not just a telephone or electronic communication) evaluation This definition includes all minor bleeding episodes that lead to medical evaluation involving direct patient contact.
- Number of participants with Non-fatal stroke [ Time Frame: Average 4 years follow-up ]Non-fatal stroke excluding confirmed intracranial haemorrhage. Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke ( including intracerebral haemorrhage and sub-arachnoid haemorrhage) which has been confirmed on appropriate imaging is excluded.
- Number of participants with Cardiovascular death [ Time Frame: Average 4 years follow-up ]Cardiovascular death (excluding confirmed intracranial haemorrhage).
- Number of participants with transient ischaemic attack [ Time Frame: Average 4 years follow-up ]A transient episode of neurological dysfunction caused by focal brain spinal cord or retinal ischemia without acute infarction
- Number of Unplanned hospitalisations per participant [ Time Frame: Average 4 years follow-up ]Defined as an official admission that is for a duration greater than 24 hours or a minimum of 2 calendar days where exact time of stay is unavailable.
- Number of participants with new diagnosis of cancer [ Time Frame: Average 4 years follow-up ]Any new cancer diagnosis excluding non melanotic skin cancer
- Number of participants with CKD progression [ Time Frame: Average 4 years follow-up ]
Defined as at least one of:
- >30% fall in eGFR over two years, or
- need for renal replacement therapy or 50% decline in eGFR, or
- new eGFR<15mL/min/1.73m2, or
- 25% decline in GFR together with a drop in GFR category
- Number of participants with new diagnosis of dementia [ Time Frame: Average 4 years follow-up ]Coded dementia (ICD, Read) from linked GP and hospital data
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 ClinicalTrials.gov identifier (NCT number): NCT03796156
|Contact: Jennifer Dumbletonemail@example.com|
|Contact: Diane Stevensonfirstname.lastname@example.org|
|Principal Investigator:||Hugh Gallagher, MD||Epsom and St Helier University Hospitals NHS Trust|
|Principal Investigator:||Paul Roderick, MD||University of Southampton|