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| ID | Type | Description | Link |
|---|---|---|---|
| B1321004 | |||
| FCAD02-CARDIAC SURGERY | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sitaxsentan (1.0 mg/kg) | Experimental |
| |
| sitaxsentan (2.0 mg/kg) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitaxsentan (Thelin) | Drug | sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | 0 hour, 0.5 hour post-separation from CPB |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | 0 hour, 6 hour post-separation from CPB |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | 0 hour, 12 hour post-separation from CPB |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period | Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine. | Immediately after cross-clamp removal up to 24 hours post-separation from CPB |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, | Philadelphia | Pennsylvania | 19104 | United States | ||
| Medical University of South Carolina |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitaxsentan (1 mg/kg) | Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB). |
| FG001 | Sitaxsentan (2 mg/kg) | Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB. |
| FG002 | Placebo | Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitaxsentan (1 mg/kg) | Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB). |
| BG001 | Sitaxsentan (2 mg/kg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | 0 hour, 0.5 hour post-separation from CPB |
|
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitaxsentan (1 mg/kg) | Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C106276 | sitaxsentan |
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| sitaxsentan (Thelin) | Drug | Sitaxsentan (2.0 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. |
|
| 0 hour, 24 hour post-separation from CPB |
| Mortality: Number of Participants Died During Surgery and Initial Hospitalization | Number of participants who died during surgery or during initial hospitalization are reported here. | During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group) |
| Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | 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. | Initial hospitalization period (up to 44 days) |
| Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs). | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. It was used to evaluate the hemodynamic profile of each participant. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. It was used to evaluate the hemodynamic profile of each participant. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 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. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Venous oxygen saturation is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. It reflects the amount of oxygen "left over" after the tissues consumption. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | SVR was calculated using formula: ([mean systemic arterial pressure - mean right atrial pressure] divided by CO)*80, where CO= SV * HR. | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
| Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | Number of participants with unanticipated perioperative (occurring at or around the time of the surgery) and postoperative (period following the surgery) blood requirements were recorded on case report forms, summarized and reported in this outcome measure. | 0 to 24 hours post-separation from CPB |
| Duration of Assisted Ventilation | Assisted Ventilation time was the time (in hours) between intubation and extubation. | 0 hour up to 24 hours post-separation from CPB |
| Duration of Intensive Care Unit (ICU) Stay | 0 hour post-separation from CPB up to 44 days |
| Duration of Initial Postoperative Hospitalization | The duration of initial postoperative hospitalization had been reported. | 0 hour post-separation from CPB up to 44 days |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| The Chattanooga Heart Institute | Chattanooga | Tennessee | 37404 | United States |
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB. |
| BG002 | Placebo | Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sitaxsentan (1 mg/kg) |
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB). |
| OG001 | Sitaxsentan (2 mg/kg) | Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB. |
| OG002 | Placebo | Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB. |
|
|
|
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | 0 hour, 6 hour post-separation from CPB |
|
|
|
|
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | 0 hour, 12 hour post-separation from CPB |
|
|
|
|
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | 0 hour, 24 hour post-separation from CPB |
|
|
|
|
| Primary | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | Number of participants who died during surgery or during initial hospitalization are reported here. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | Posted | Number | participants | During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group) |
|
|
|
| Primary | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | Posted | Number | participants | Initial hospitalization period (up to 44 days) |
|
|
|
| Secondary | Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period | Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine. | Data was not collected, since this outcome was not analyzed as per Sponsor's discretion. | Posted | Immediately after cross-clamp removal up to 24 hours post-separation from CPB |
|
|
| Secondary | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the last observation carried forward (LOCF) method. | Posted | Mean | Standard Deviation | liters per minute | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| Secondary | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| Secondary | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs). | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | percentage of red blood cells in blood | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| Secondary | Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | beats per minute (bpm) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| 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) | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. It was used to evaluate the hemodynamic profile of each participant. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | mmHg | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| 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) | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. It was used to evaluate the hemodynamic profile of each participant. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| Secondary | Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 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. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | (dynes*second) per centimeter^5 | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| 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) | Venous oxygen saturation is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. It reflects the amount of oxygen "left over" after the tissues consumption. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
|
| Secondary | Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | SVR was calculated using formula: ([mean systemic arterial pressure - mean right atrial pressure] divided by CO)*80, where CO= SV * HR. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | (dynes*second) per centimeter^5 | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
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| 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) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | mmHg | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
|
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| Secondary | Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milliliters (mL) | 0, 0.5, 6, 12, 24 hours post-separation from CPB |
|
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| Secondary | Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements | Number of participants with unanticipated perioperative (occurring at or around the time of the surgery) and postoperative (period following the surgery) blood requirements were recorded on case report forms, summarized and reported in this outcome measure. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | Posted | Number | participants | 0 to 24 hours post-separation from CPB |
|
|
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| Secondary | Duration of Assisted Ventilation | Assisted Ventilation time was the time (in hours) between intubation and extubation. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | Posted | Median | Full Range | hours | 0 hour up to 24 hours post-separation from CPB |
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| Secondary | Duration of Intensive Care Unit (ICU) Stay | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | Posted | Median | Full Range | days | 0 hour post-separation from CPB up to 44 days |
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| Secondary | Duration of Initial Postoperative Hospitalization | The duration of initial postoperative hospitalization had been reported. | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | Posted | Median | Full Range | days | 0 hour post-separation from CPB up to 44 days |
|
|
|
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | Sitaxsentan (2 mg/kg) | Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB. | 5 | 10 | 9 | 10 |
| EG002 | Placebo | Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB. | 4 | 10 | 9 | 10 |
| Cardiac arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Purulent discharge | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Methicillin-resistant staphylococcal aureus test positive | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Vascular resistance systemic decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Mean Difference (Net) |
| -174.5 |
| 2-Sided |
| 95 |
| -396.8 |
| 47.9 |
| Superiority or Other (legacy) |
| Mean Difference (Net) |
| -110.3 |
| 2-Sided |
| 95 |
| -331.7 |
| 111.0 |
| Superiority or Other (legacy) |
| Mean Difference (Net) |
| -199.8 |
| 2-Sided |
| 95 |
| -425.0 |
| 25.5 |
| Superiority or Other (legacy) |
|
|
| Hemodynamic collapse |
|
| Re-operation |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|
|
| Change at 6 hours post-separation from CPB |
|
| Change at 12 hours post-separation from CPB |
|
| Change at 24 hours post-separation from CPB |
|