N/A
N=140
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Hemorrhage, Surgical · Blood Loss, Surgical · Blood Loss, Postoperative · Hemorrhage Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04976530 ↗Enrolled (actual)
140
Serious AEs
33.3%
Results posted
Apr 2025
Primary outcome: Primary: Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population — 2103; 2244 number of wins — p=0.748
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DrugSorb-ATR system (Device); Sham comparator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CytoSorbents, Inc
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population |
2103; 2244 | 0.748 |
| PRIMARY Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population |
1310; 1741 | 0.202 |
| PRIMARY Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population |
2005; 2336 | 0.451 |
| PRIMARY Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population |
1178; 1868 | 0.041 sig |
| SECONDARY Chest Tube Drainage, mITT Population |
487; 430 | 0.427 |
| SECONDARY Chest Tube Drainage, i-CABG PP Population |
487; 410 | 0.042 sig |
| SECONDARY Chest Tube Drainage, mITT Population |
487; 430 | 0.427 |
| SECONDARY Chest Tube Drainage, i-CABG PP Population |
487; 410 | 0.042 sig |
| SECONDARY Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population |
3; 2.5 | — |
| SECONDARY PRBC Transfusions, (Units) I-CABG PP Population |
3; 2 | — |
| SECONDARY Platelet Transfusions (Units), mITT Population |
2; 2 | — |
| SECONDARY Platelet Transfusions, (Units), I-CABG PP Population |
2; 2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female 18 years of age or older, with documented full, written informed consent
- Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Exclusion Criteria
- CT surgery occurring 3 days or greater following ticagrelor discontinuation
- Heart-lung transplant procedures
- Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
- Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis [HITT], perioperative platelet count 1.5)
- Prohibited concomitant antithrombotic medications as defined in the study protocol
- Acute sickle cell crisis
- Known allergy to device components
- Active (untreated) systemic infection
- History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
- Women with positive pregnancy test during current admission or who are breast-feeding
- Life expectancy <30 days
- Inability to comply with requirements of the study protocol
- Treatment with investigational drug or device within 30 days of current surgery
- Previous enrollment in this trial
Data sourced from ClinicalTrials.gov (NCT04976530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.