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Completed

NCT Number: NCT02998905

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Heart Diseases Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

acetylsalicylic acid

Drug

Acetylsalicylic acid 81 mg/day

Primary outcomes

  1. Recruitment rate

    Time frame: Through study completion; ~ 30 months

    The mean number of patients randomized per site per year.

  2. 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

Secondary outcomes

  1. Refusal rate

    Time frame: Through study completion; average of 1 year

    Average number of eligible patients per site who refuse consent.

  2. Retention rate

    Time frame: Through study completion; average of 1 year

    Randomized patients who completed 6 months of follow-up on drug or died during trial participation.

  3. Ischemic stroke

    Time frame: Through study completion; average of 1 year

    Development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke.

  4. Intracerebral hemorrhage

    Time frame: Through study completion; average of 1 year

    A neurologic deficit associated with an intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy.

  5. Fatal stroke

    Time frame: Through study completion; average of 1 year

    Death that is attributable to an ischemic stroke or intracerebral hemorrhage.

  6. Myocardial infarction

    Time frame: Through study completion; average of 1 year

    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.

  7. All-cause mortality

    Time frame: Through study completion; average of 1 year

    Persistent and irreversible absence of brain or brainstem function.

  8. Systemic thromboembolism

    Time frame: Through study completion; average of 1 year

    Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage.

  9. Major hemorrhage

    Time frame: Through study completion; average of 1 year

    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.

  10. Intracranial hemorrhage

    Time frame: Through study completion; average of 1 year

    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.

  11. Composite of all stroke, myocardial infarct, systemic thromboembolism or death

    Time frame: Through study completion; average of 1 year

    Composite of all stroke, myocardial infarct, systemic thromboembolism or death

  12. Modified Rankin Scale (mRS)

    Time frame: Through study completion; average of 1 year

    Average mRS score

  13. Montreal Cognitive Assessment (MOCA)

    Time frame: Through study completion; average of 1 year

    Average MOCA score

Other outcomes

  1. Weighted net clinical benefit

    Time frame: Through study completion; average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: NASPAF-ICH

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 21, 2016
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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