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NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH (NASPAF-ICH)

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ClinicalTrials.gov Identifier: NCT02998905
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ashkan Shoamanesh, Population Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Intracerebral Hemorrhage Drug: NOAC Drug: Acetylsalicylic Acid Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: NOAC
Apixaban or dabigatran or edoxaban or rivaroxaban
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.

Active Comparator: Acetylsalicylic Acid
Acetylsalicylic acid
Drug: Acetylsalicylic Acid
Acetylsalicylic acid 81 mg/day




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998905


Contacts
Contact: Ashkan Shoamanesh, MD FRCPC 905-527-4322 ext 40561 ashkan.shoamanesh@phri.ca
Contact: Jodi E Miller, PhD 905-527-4322 ext 40561 jodi.miller@phri.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Anitha Jambula       Anitha.Jambula@albertahealthservices.ca   
Principal Investigator: Shelagh B Coutts, MD FRCPC         
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Contact: Leka Ravindran       lsivakum@ualberta.ca   
Principal Investigator: Ken Butcher, MD FRCPC         
Canada, British Columbia
Vancouver Coastal Health Research Institute Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Karina Villaluna       karina@bcstrokecentre.ca   
Principal Investigator: Thalia S Field, MD FRCPC         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L9G1J8
Contact: Jordan Knapman, MSc.    905.521.2100 ext 44434    knapmanj@hhsc.ca   
London Health Sciences Centre - University Hospital Not yet recruiting
London, Ontario, Canada
Contact: Belinda Amato Marziali       Belinda.AmatoMarziali@lhsc.on.ca   
Principal Investigator: Alexander Khaw, MD FRCPC         
Trilllium Brain and Spine Not yet recruiting
Mississauga, Ontario, Canada
Contact: Suzanne Bickford       suzanne.bickford@brainandspine.ca   
Principal Investigator: Manu Mehdiratta, MD FRCPC         
The Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada
Contact: Rany Shamloul       rshamloul@ohri.ca   
Principal Investigator: Dariush Dowlatshahi, MD FRCPC         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Samantha Senyshyn       samantha.senyshyn@sunnybrook.ca   
Principal Investigator: David Gladstone, MD FRCPC         
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Libby Kalman       Libby.Kalman@uhn.ca   
Principal Investigator: Alexsandra Pikula, MD FRCPC         
Canada, Quebec
Hopital Notre-Dame du CHUM Not yet recruiting
Montréal, Quebec, Canada
Contact: Marlene LaPierre       marlene.lapierre.chum@ssss.gouv.qc.ca   
Principal Investigator: Laura Gioia, MD FRCPC         
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Ashkan Shoamanesh, MD FRCPC Population Health Research Institute

Responsible Party: Ashkan Shoamanesh, Assistant Professor of Medicine (Neurology), Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02998905     History of Changes
Other Study ID Numbers: NASPAF-ICH
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Hemorrhage
Cerebral Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics