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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

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ClinicalTrials.gov Identifier: NCT03907046
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : January 5, 2023
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 8, 2019
Last Update Posted Date January 5, 2023
Actual Study Start Date  ICMJE January 28, 2020
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)		 Stroke or death [ Time Frame: Up to 3 years ]
Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)		 Stroke or death [ Time Frame: Up to 3 years ]
Stroke of any type (ischemic or hemorrhagic) or death from any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)		 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)		 Modified Rankin Scale (mRS) score [ Time Frame: Change from baseline to 12 months; change over duration of follow-up ]
Functional outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Official Title  ICMJE Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
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.
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 non-valvular AF. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Intracerebral Hemorrhage
  • Atrial Fibrillation
Intervention  ICMJE
  • Drug: Apixaban
    Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
    Other Name: Eliquis
  • Drug: Aspirin
    Aspirin is an oral antiplatelet drug.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Apixaban
  • Placebo Comparator: Aspirin
    Aspirin dose will be 81 mg tablet once daily.
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2019)		 700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age at least 18 years
  • Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  • Can be randomized within 14-180 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
  • Provision of signed and dated informed consent form by patient or legally authorized representative
  • For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

  • Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
  • History of earlier ICH within 12 months preceding index event
  • Active infective endocarditis
  • 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 coronary stent).
  • 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 10^9/L) that is chronic in the judgment of the investigator
  • Pregnant or breastfeeding
  • Known allergy to aspirin or apixaban
  • Concomitant participation in a competing trial
  • Considered by the investigator to have a condition that precludes safe or active participation in the trial
  • Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
  • ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kevin N Sheth, MD 443-615-4729 kevin.sheth@yale.edu
Contact: Hooman Kamel, MD 646-962-8284 hok9010@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03907046
Other Study ID Numbers  ICMJE 2000026409
1U01NS106513-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Kevin N Sheth, MD Yale School of Medicine
Principal Investigator: Hooman Kamel, MD Weill Medical College of Cornell University
PRS Account Yale University
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP