A Phase 2 interventional study of NOAC and Acetylsalicylic Acid in Atrial Fibrillation and Intracerebral Hemorrhage, sponsored by Population Health Research Institute. Completed at 9 sites in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by Population Health Research Institute · Phase 2, Interventional, and Treatment
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Apixaban or dabigatran or edoxaban or rivaroxaban
Drug: NOAC
Acetylsalicylic acid
Drug: Acetylsalicylic Acid
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.
Acetylsalicylic acid 81 mg/day
Recruitment rate
The mean number of patients randomized per site per year.
Time frame: Through study completion; ~ 30 months
Composite of ischemic stroke and recurrent intracerebral hemorrhage
The composite of ischemic stroke and recurrent intracerebral hemorrhage
Time frame: Through study completion; average of 1 year
Refusal rate
Average number of eligible patients per site who refuse consent.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion; average of 1 year
Fatal stroke
Death that is attributable to an ischemic stroke or intracerebral hemorrhage.
Time frame: 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.
Time frame: Through study completion; average of 1 year
All-cause mortality
Persistent and irreversible absence of brain or brainstem function.
Time frame: Through study completion; average of 1 year
Systemic thromboembolism
Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Through study completion; average of 1 year
Modified Rankin Scale (mRS)
Average mRS score
Time frame: Through study completion; average of 1 year
Montreal Cognitive Assessment (MOCA)
Average MOCA score
Time frame: Through study completion; average of 1 year
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.
Time frame: Through study completion; average of 1 year
Plan to share: No
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