Phase 2 N=29 Randomized Treatment

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

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

Bottom Line

View on ClinicalTrials.gov: NCT00838383 ↗

Enrolled (actual)

Serious AEs

37.9%

Results posted

Sep 2022

Primary outcome: 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 percent change — p=0.5307

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sitaxsentan (Thelin) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 48+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2008

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.