Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)
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| ClinicalTrials.gov Identifier: NCT03907046 |
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Recruitment Status :
Recruiting
First Posted : April 8, 2019
Last Update Posted : March 21, 2024
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Sponsor:
Yale University
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Yale University
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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 |
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 : | 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 |
| Actual Study Start Date : | January 28, 2020 |
| Estimated Primary Completion Date : | April 2027 |
| Estimated Study Completion Date : | April 2027 |
| Arm | Intervention/treatment |
|---|---|
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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).
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Drug: Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
Other Name: Eliquis |
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Placebo Comparator: Aspirin
Aspirin dose will be 81 mg tablet once daily.
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Drug: Aspirin
Aspirin is an oral antiplatelet drug. |
Primary Outcome Measures :
- 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 :
- 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)
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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 14-180 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
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
| Contact: Kevin N Sheth, MD | 443-615-4729 | kevin.sheth@yale.edu | |
| Contact: Hooman Kamel, MD | 646-962-8284 | hok9010@med.cornell.edu |
Locations
Show 156 study locations
Sponsors and Collaborators
Yale University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Kevin N Sheth, MD | Yale School of Medicine | |
| Principal Investigator: | Hooman Kamel, MD | Weill Medical College of Cornell University |
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT03907046 |
| Other Study ID Numbers: |
2000026409 1U01NS106513-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 8, 2019 Key Record Dates |
| Last Update Posted: | March 21, 2024 |
| Last Verified: | March 2024 |
| 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 |