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Anticoagulation for Stroke Prevention and Recovery After ICH (ASPIRE)

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ClinicalTrials.gov Identifier: NCT03907046
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Atrial Fibrillation Drug: Apixaban Drug: Aspirin Phase 3

Detailed Description:
ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Apixaban
Apixaban dosing will be 5 mg tablet in morning and 5 mg tablet in evening. A reduced dose of 2.5 mg tablet in morning and 2.5 mg tablet in evening will be used if: (1) ≥2 of the following are present: age ≥80 years, body weight ≤60 kg, or serum creatinine 1.5-2.4 mg/dL, or (2) Patient is taking a strong CYP3A4/pGP inhibitor (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).
Drug: Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
Other Name: Eliquis

Placebo Comparator: Aspirin
Aspirin dose will be 81 mg tablet once daily.
Drug: Aspirin
Aspirin is an oral antiplatelet drug.




Primary Outcome Measures :
  1. Stroke or death [ Time Frame: Up to 3 years ]
    Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause


Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) score [ Time Frame: Change from baseline to 12 months; change over duration of follow-up ]
    Measure of neurologic disability (0=no disability to 6=dead)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years
  • Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  • Can be randomized within 14-120 days after ICH onset
  • Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
  • CHA2DS2-VASc score ≥ 2
  • Provision of signed and dated informed consent form by patient or legally authorized representative
  • Able to comply with all study procedures and available for duration of the study
  • For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

  • History of ICH before index event
  • Active infective endocarditis
  • Lobar ICH with cerebral amyloid angiopathy
  • Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent MI).
  • Previous or planned left atrial appendage closure
  • Clinically significant bleeding diathesis
  • Serum creatinine ≥2.5 mg/dL
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
  • Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 109/L) that is chronic in the judgment of the investigator
  • Life expectancy <1 year
  • Pregnant or breastfeeding
  • Known allergy to aspirin or apixaban
  • Concomitant participation in a competing therapeutic trial
  • Considered by the investigator to have a condition that precludes safe participation in the trial
  • Unwilling to discontinue prohibited medications

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): NCT03907046


Contacts
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Contact: Kevin N Sheth, MD 203-737-8051 kevin.sheth@yale.edu
Contact: Hooman Kamel, MD 646-962-8284 hok9010@med.cornell.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kevin N Sheth, MD Yale School of Medicine
Principal Investigator: Hooman Kamel, MD Weill Medical College of Cornell University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03907046     History of Changes
Other Study ID Numbers: 2019-0136
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Atrial Fibrillation
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
Apixaban
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