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NCT04976530 · ClinicalTrials.gov registry record · NA
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
A NA study, sponsored by CytoSorbents.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
NCT04976530: Completed NA study, sponsored by CytoSorbents.
NCT04976530 is a NA study that has completed, run by CytoSorbents. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04976530, a NA study, has completed, sponsored by CytoSorbents.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
Study Summary
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
Primary Outcome
Incidence of periop bleeding, primary effectiveness composite endpoint, mITT population. Primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm
Interventions
- DEVICE Sham comparator
- DEVICE DrugSorb-ATR system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2023-08-07 |
| Phase | NA |
What the finished NCT04976530 record still lists
NCT04976530 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham comparator is the first listed.
NCT04976530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04976530 about?
NCT04976530 is a clinical study titled "Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)". Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
What is the current status of trial NCT04976530?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2021-08-31. Estimated completion is 2023-08-07.
What interventions are being tested in trial NCT04976530?
The interventions under investigation include: Sham comparator (DEVICE), DrugSorb-ATR system (DEVICE).
Who is sponsoring clinical trial NCT04976530?
This trial is sponsored by CytoSorbents, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04976530's enrollment target sits among peer trials
140 713th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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