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NCT03661528 · ClinicalTrials.gov registry record · Phase 4
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
A Phase 4 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 530
- Enrollment target
NCT03661528: Completed Phase 4 study, sponsored by Alexion Pharmaceuticals.
NCT03661528 is a Phase 4 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 530 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03661528, a Phase 4 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 530 participants
- Enrollment target
Study Summary
Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
Primary Outcome
Effective hemostasis was defined as a change from baseline in National Institutes of Health Stroke Scale (NIHSS) of + 6 or less at the 12 hour timepoint and ≤35% increase in haematoma volume compared to baseline on a repeat computed tomography (CT) or magnetic resonance imaging (MRI) scan at 12 hours and no rescue therapies administered between 3 hours and 12 hours after randomization (defined as excellent or good hemostasis). The NIHSS is a validated quantitative assessment tool to measure stro
Interventions
- DRUG Usual Care
- DRUG andexanet alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 4 |
What the finished NCT03661528 record still lists
NCT03661528 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT03661528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03661528 about?
NCT03661528 is a clinical study titled "Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor". Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
What is the current status of trial NCT03661528?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 530 participants. The study started on 2019-06-06. Estimated completion is 2023-08-09.
What interventions are being tested in trial NCT03661528?
The interventions under investigation include: Usual Care (DRUG), andexanet alfa (DRUG).
Who is sponsoring clinical trial NCT03661528?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03661528's enrollment target sits among peer trials
530 157th of 2000 higher than 1,844 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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