Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

NCT00838383 | Completed Phase 2 Results

• 2 other identifiers: B1321004FCAD02-CARDIAC SURGERY
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

multi-center; placebo-controlled; randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

Secondary Outcomes (16)

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

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

• Change From 0 Hour in Cardiac Output (CO) 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 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)

  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)

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

Study Arms (3)

sitaxsentan (1.0 mg/kg)

EXPERIMENTAL

Drug: sitaxsentan (Thelin)

sitaxsentan (2.0 mg/kg)

EXPERIMENTAL

Drug: sitaxsentan (Thelin)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

sitaxsentan (Thelin) DRUG

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

Also known as: sitaxsentan, Thelin

sitaxsentan (1.0 mg/kg)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 48 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Requires an emergent or "emergency" CABG and/or cardiac valve replacement.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

University of Pennsylvania,

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Chattanooga Heart Institute

Chattanooga, Tennessee, 37404, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

sitaxsentan

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: August 10, 2006
• Primary Completion: March 31, 2008
• Study Completion: March 31, 2008
• Last Updated: September 8, 2022
• Results First Posted: September 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)