Phase 2
Completed N=29
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
Cardiac Surgery Subjects · Subjects Undergoing CABG and/or Cardiac Valve Replacement
Source: ClinicalTrials.gov NCT00838383 ↗
Enrolled (actual)
29
Serious AEs
37.9%
Results posted
Sep 2022
Primary outcomePrimary: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) — -7.75; -10.94; 62.22 percent change — p=0.5307
Summary
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) |
-7.75; -10.94; 62.22 | 0.5307 |
| PRIMARY Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) |
39.36; -12.01; 173.68 | 0.2735 |
| PRIMARY Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) |
31.42; -12.32; 98.03 | 0.5505 |
| PRIMARY Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) |
18.06; -15.99; 195.64 | 0.1412 |
| PRIMARY Mortality: Number of Participants Died During Surgery and Initial Hospitalization |
0; 0; 0; 2; 1; 0 | — |
| PRIMARY Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period |
— | — |
| SECONDARY Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
5.48; 5.51; 4.83; 0.22; -0.36; 0.16 | — |
| SECONDARY Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) |
9.89; 8.10; 9.22; 2.11; 0.40; 0.33 | — |
| SECONDARY Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
25.56; 26.46; 25.30; 1.77; 3.29; 2.30 | — |
| SECONDARY Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
80.11; 84.50; 77.80; -1.56; -1.70; -2.80 | — |
| SECONDARY Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) |
19.27; 26.02; 20.81; -1.14; -3.51; -0.41 | — |
| SECONDARY Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
10.38; 14.43; 12.50; 0.25; -0.43; -0.88 | — |
| SECONDARY Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
125.28; 166.22; 112.79; -31.32; -33.47; -4.04 | — |
| SECONDARY Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
75.14; 73.25; 72.44; 0.14; 0.88; 2.44 | — |
| SECONDARY Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
978.37; 959.89; 1155.39; -117.39; 1.14; -20.25 | — |
| SECONDARY Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) |
69.01; 71.90; 72.55; -5.80; -3.70; 2.21 | — |
| SECONDARY Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) |
105.56; 124.50; 107.50; -42.11; 0.50; -16.88 | — |
| SECONDARY Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements |
0; 3; 0 | — |
| SECONDARY Duration of Assisted Ventilation |
12; 23; 21 | — |
| SECONDARY Duration of Intensive Care Unit (ICU) Stay |
4; 6; 5 | — |
| SECONDARY Duration of Initial Postoperative Hospitalization |
8; 11; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).
Exclusion Criteria
- Requires an emergent or "emergency" CABG and/or cardiac valve replacement.
Data sourced from ClinicalTrials.gov (NCT00838383). 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. Informational only — not medical advice.