Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00838383 | Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery | PHASE2 | COMPLETED | 29 | — | — | Aug 10, 2006 | Mar 31, 2008 | Sep 8, 2022 | 3 | United States |
PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 6 hour in participants were summarized and reported.
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 12 hour in participants were summarized and reported.
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 24 hour in participants were summarized and reported.
Number of participants who died during surgery or during initial hospitalization are reported here.
Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported.
| Arm | Type | Description |
|---|---|---|
| sitaxsentan (1.0 mg/kg) | EXPERIMENTAL | - |
| sitaxsentan (2.0 mg/kg) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| sitaxsentan (Thelin) | DRUG | sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. |
| Placebo | DRUG | Placebo will begin immediately following cross-clamp release and 12 hours post-CPB. |
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 ...