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To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.
The NASPAF-ICH study is an open-label, randomized, controlled, phase II study that will assess the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with acetylsalicylic acid (ASA) for stroke prevention in patients with high-risk atrial fibrillation and previous intracerebral hemorrhage, as well as provide evidence of efficacy and safety for planning of a phase III trial. Recruitment will occur at 10 high-volume stroke research centres across Canada over 2 years, at which 100 adult patients with high-risk atrial fibrillation (CHADS2 ≥2) and previous spontaneous or traumatic ICH (intraparenchymal or intraventricular hemorrhage while on or off anticoagulation) will be randomly assigned to receive a NOAC (particular agent at the discretion of the local investigator) or ASA 81 mg per day. Patients will be followed for a mean of 1 year to a common end-study date. The feasibility of recruitment will also be tested. The investigators estimate that five patients per year per centre can be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOAC | Experimental | Apixaban or dabigatran or edoxaban or rivaroxaban |
|
| Acetylsalicylic Acid | Active Comparator | Acetylsalicylic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOAC | Drug | Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The mean number of patients randomized per site per year. | Through study completion; ~ 30 months |
| Composite of ischemic stroke and recurrent intracerebral hemorrhage | The composite of ischemic stroke and recurrent intracerebral hemorrhage | Through study completion; average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Refusal rate | Average number of eligible patients per site who refuse consent. | Through study completion; average of 1 year |
| Retention rate | Randomized patients who completed 6 months of follow-up on drug or died during trial participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted net clinical benefit | Weighted net clinical benefit factoring the impact of ischemic stroke, intracerebral hemorrhage, non-intracerebral intracranial hemorrhage, major extracranial hemorrhage and myocardial infarction on death and disability. | Through study completion; average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashkan Shoamanesh, MD FRCPC | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 4N1 | Canada | ||
| University of Alberta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36700520 | Derived | Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Not provided
| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Acetylsalicylic Acid | Drug | Acetylsalicylic acid 81 mg/day |
|
| Through study completion; average of 1 year |
| Ischemic stroke | Development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke. | Through study completion; average of 1 year |
| Intracerebral hemorrhage | A neurologic deficit associated with an intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy. | Through study completion; average of 1 year |
| Fatal stroke | Death that is attributable to an ischemic stroke or intracerebral hemorrhage. | Through study completion; average of 1 year |
| Myocardial infarction | Defined by presence of at least one of the following a compatible clinical history and characteristic serum enzymes changes with or without electrocardiographic abnormalities; clinical history and serial ST-segment and T-wave changes which are specifically located with respect to the electrocardiographic leads accompanied by elevation of CPK-MB isoenzyme or troponin in serum; the development of large Q-waves on electrocardiography associated with changes in the ST-segments and T-waves in specific and appropriate leads which indicate the location of the infarct, even in the absence of symptoms or abnormalities in serum enzymes; development of discrete, segmental left ventricular systolic wall motion abnormality concurrent with compatible clinical history, electrocardiographic changes or serum enzyme abnormalities; or histopathological evidence of subacute myocardial necrosis. | Through study completion; average of 1 year |
| All-cause mortality | Persistent and irreversible absence of brain or brainstem function. | Through study completion; average of 1 year |
| Systemic thromboembolism | Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage. | Through study completion; average of 1 year |
| Major hemorrhage | Bleeding accompanied by one or more of the following - a decrease in the hemoglobin level of ≥20 g per liter over a 24-hour period, transfusion of ≥2 units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding. | Through study completion; average of 1 year |
| Intracranial hemorrhage | Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy. | Through study completion; average of 1 year |
| Composite of all stroke, myocardial infarct, systemic thromboembolism or death | Composite of all stroke, myocardial infarct, systemic thromboembolism or death | Through study completion; average of 1 year |
| Modified Rankin Scale (mRS) | Average mRS score | Through study completion; average of 1 year |
| Montreal Cognitive Assessment (MOCA) | Average MOCA score | Through study completion; average of 1 year |
| Edmonton |
| Alberta |
| Canada |
| Vancouver Coastal Health Research Institute | Vancouver | British Columbia | V6T 2B5 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L9G1J8 | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | Canada |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |