Anticoagulation for Stroke Prevention and Recovery After ICH (ASPIRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03907046|
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : April 11, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
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.
Aspirin is an oral antiplatelet drug.
- Stroke or death [ Time Frame: Up to 3 years ]Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
- 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)
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
|Contact: Kevin N Sheth, MDemail@example.com|
|Contact: Hooman Kamel, MDfirstname.lastname@example.org|
|Principal Investigator:||Kevin N Sheth, MD||Yale School of Medicine|
|Principal Investigator:||Hooman Kamel, MD||Weill Medical College of Cornell University|