NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH

Atrial Fibrillation Clinical Trial

— NASPAF-ICH  

Official title:

Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998905
• Other study ID #: NASPAF-ICH
• Status: Completed
• Phase: Phase 2
• Start date: April 26, 2017
• Est. completion date: February 18, 2020

Study information

• Verified date: March 2020
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 18, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Previous primary intracerebral hemorrhage

• Atrial fibrillation (CHADS2 = 2)

Exclusion Criteria:

• Non-stroke indication for antiplatelet or anticoagulant therapy

• Recent intracerebral hemorrhage within 14 days

• Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis

• Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event

• Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg

• Known hypersensitivity to either ASA or NOACs

• Inability to adhere to study procedures

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• NOAC
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
Acetylsalicylic acid 81 mg/day

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	Hopital Notre-Dame du CHUM	Montréal	Quebec
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Vancouver Coastal Health Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Recruitment rate	The mean number of patients randomized per site per year.	Through study completion; ~ 30 months
Primary	Composite of ischemic stroke and recurrent intracerebral hemorrhage	The composite of ischemic stroke and recurrent intracerebral hemorrhage	Through study completion; average of 1 year
Secondary	Refusal rate	Average number of eligible patients per site who refuse consent.	Through study completion; average of 1 year
Secondary	Retention rate	Randomized patients who completed 6 months of follow-up on drug or died during trial participation.	Through study completion; average of 1 year
Secondary	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
Secondary	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
Secondary	Fatal stroke	Death that is attributable to an ischemic stroke or intracerebral hemorrhage.	Through study completion; average of 1 year
Secondary	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
Secondary	All-cause mortality	Persistent and irreversible absence of brain or brainstem function.	Through study completion; average of 1 year
Secondary	Systemic thromboembolism	Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage.	Through study completion; average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Modified Rankin Scale (mRS)	Average mRS score	Through study completion; average of 1 year
Secondary	Montreal Cognitive Assessment (MOCA)	Average MOCA score	Through study completion; average of 1 year