Skip to main content
OpenTrials
Completed

NCT Number: NCT00838383

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Surgery Subjects Subjects Undergoing CABG and/or Cardiac Valve Replacement

Age range

48 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania,, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sitaxsentan (Thelin)

Drug

sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.

Other names: sitaxsentan, Thelin

Placebo

Drug

Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.

Primary outcomes

  1. Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0 hour, 0.5 hour post-separation from 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.

  2. Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0 hour, 6 hour post-separation from 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.

  3. Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0 hour, 12 hour post-separation from 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.

  4. Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0 hour, 24 hour post-separation from 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.

  5. Mortality: Number of Participants Died During Surgery and Initial Hospitalization

    Time frame: 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 who died during surgery or during initial hospitalization are reported here.

  6. Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation

    Time frame: Initial hospitalization period (up to 44 days)

    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.

Secondary outcomes

  1. Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period

    Time frame: Immediately after cross-clamp removal up to 24 hours post-separation from CPB

    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.

  2. Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

    CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant.

  3. Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

  4. Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

    The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs).

  5. Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

    Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points.

  6. Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from 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.

  7. Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from 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.

  8. Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from 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.

  9. Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from 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.

  10. Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

    SVR was calculated using formula: ([mean systemic arterial pressure - mean right atrial pressure] divided by CO)*80, where CO= SV * HR.

  11. Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

  12. Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)

    Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB

  13. Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements

    Time frame: 0 to 24 hours post-separation from CPB

    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.

  14. Duration of Assisted Ventilation

    Time frame: 0 hour up to 24 hours post-separation from CPB

    Assisted Ventilation time was the time (in hours) between intubation and extubation.

  15. Duration of Intensive Care Unit (ICU) Stay

    Time frame: 0 hour post-separation from CPB up to 44 days

  16. Duration of Initial Postoperative Hospitalization

    Time frame: 0 hour post-separation from CPB up to 44 days

    The duration of initial postoperative hospitalization had been reported.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY

Acronym: FCAD02

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2009
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.