Atrial FibrillationPhase 2NASPAF-ICHNCT02998905
NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH
A Phase 2 study testing NOAC and Acetylsalicylic Acid in people with Atrial Fibrillation and Intracerebral Hemorrhage, run by Population Health Research Institute at 9 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atrial Fibrillation, Intracerebral Hemorrhage
- What is being tested?
- NOAC and Acetylsalicylic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesCanada
- Study dates
- 26 Apr 2017to 18 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous primary intracerebral hemorrhage
- Atrial fibrillation (CHADS2 ≥ 2)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta
Hamilton Health Sciences
Hamilton, Ontario, L9G1J8
London Health Sciences Centre - University Hospital
London, Ontario
Hopital Notre-Dame du CHUM
Montreal, Quebec
The Ottawa Hospital Research Institute
Ottawa, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto Western Hospital
Toronto, Ontario
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Intracerebral Hemorrhage
- Being tested
- NOAC, Acetylsalicylic Acid
- Medical subject headings
- Atrial Fibrillation, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOACDrug
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 AcidDrug
Acetylsalicylic acid 81 mg/day
| Study group | Role | What they receive |
|---|---|---|
| NOAC | Experimental | Apixaban or dabigatran or edoxaban or rivaroxaban Receives: Drug: NOAC |
| Acetylsalicylic Acid | Active comparator | Acetylsalicylic acid Receives: Drug: Acetylsalicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The mean number of patients randomized per site per year.
Measured: Through study completion; ~ 30 months
Composite of ischemic stroke and recurrent intracerebral hemorrhage
The composite of ischemic stroke and recurrent intracerebral hemorrhage
Measured: Through study completion; average of 1 year
Secondary outcomes (13)
Refusal rate
Average number of eligible patients per site who refuse consent.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion; average of 1 year
Fatal stroke
Death that is attributable to an ischemic stroke or intracerebral hemorrhage.
Measured: 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.
Measured: Through study completion; average of 1 year
All-cause mortality
Persistent and irreversible absence of brain or brainstem function.
Measured: Through study completion; average of 1 year
Systemic thromboembolism
Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion; average of 1 year
Modified Rankin Scale (mRS)
Average mRS score
Measured: Through study completion; average of 1 year
Montreal Cognitive Assessment (MOCA)
Average MOCA score
Measured: Through study completion; average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start26 Apr 2017
- Primary completion31 Oct 2019
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashkan Shoamanesh, Population Health Research Institute
- Investigators
- Ashkan Shoamanesh, MD FRCPC, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998905
- Sponsor's protocol ID
- NASPAF-ICH
- Acronym
- NASPAF-ICH
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2016
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36700520
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
- ClinicalTrials.gov ID
- NCT02998905
- Acronym / sponsor ID
- NASPAF-ICH / NASPAF-ICH
- Conditions
- Atrial Fibrillation, Intracerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOAC | Experimental | Drug: NOACApixaban or dabigatran or edoxaban or rivaroxaban |
| Acetylsalicylic Acid | Active comparator | Drug: Acetylsalicylic AcidAcetylsalicylic acid |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous primary intracerebral hemorrhage
- Atrial fibrillation (CHADS2 ≥ 2)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOACApixaban 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. | Drug | NOAC |
| Acetylsalicylic AcidAcetylsalicylic acid 81 mg/day | Drug | Acetylsalicylic Acid |
Primary outcome
Recruitment rate
Time frame: Through study completion; ~ 30 months
The mean number of patients randomized per site per year.
Composite of ischemic stroke and recurrent intracerebral hemorrhage
Time frame: Through study completion; average of 1 year
The composite of ischemic stroke and recurrent intracerebral hemorrhage
13 secondary outcomes
Refusal rate
Time frame: Through study completion; average of 1 year
Retention rate
Time frame: Through study completion; average of 1 year
Ischemic stroke
Time frame: Through study completion; average of 1 year
Intracerebral hemorrhage
Time frame: Through study completion; average of 1 year
Fatal stroke
Time frame: Through study completion; average of 1 year
Myocardial infarction
Time frame: Through study completion; average of 1 year
All-cause mortality
Time frame: Through study completion; average of 1 year
Systemic thromboembolism
Time frame: Through study completion; average of 1 year
Major hemorrhage
Time frame: Through study completion; average of 1 year
Intracranial hemorrhage
Time frame: Through study completion; average of 1 year
Composite of all stroke, myocardial infarct, systemic thromboembolism or death
Time frame: Through study completion; average of 1 year
Modified Rankin Scale (mRS)
Time frame: Through study completion; average of 1 year
Montreal Cognitive Assessment (MOCA)
Time frame: Through study completion; average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 36700520Cochrane 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.
- Individual participant dataSharing planned: No
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashkan Shoamanesh, MD FRCPC principal investigator
Population Health Research Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOAC and Acetylsalicylic Acid in people with Atrial Fibrillation and Intracerebral Hemorrhage, run by Population Health Research Institute at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion; ~ 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.