Trial · NCT00744211

Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

NCT00744211, Not applicable, Completed, VA Office of Research and Development; results first posted 2017-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Proteolytic Enzyme Induction Within the Human Myocardial Interstitium. Trials, record NCT00744211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00744211

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
NCT number: NCT00744211
Status: Completed
Phases: Not applicable
Enrollment: 29 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Heart Disease
Interventions: 1mg/kg sitaxsentan sodium, 2mg/kg sitaxsentan sodium, Vehicle
First posted: 2008-08-29
Last updated: 2026-08-13
Results first posted: 2017-11-09
Limitations and caveats: Small sample size, which in turn can result in a disproportionate number of patients with greater pre-operative risk profiles randomized to one treatment group.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pulmonary Vascular Resistance	Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)	Pulmonary Vascular Resistance (d.s.cm-5)
Secondary	Plasma Endothelin-1	Baseline, 0, 6, 12 and 24 hours post-CPB	Plasma Endothelin-1 (fmol/mL)
Other	Sitaxsentan Levels	0, 6, 12 and 24 hours post-CPB	Sitaxsentan levels (microg/mL)
Other	Number of Other Adverse Events By Type	up to 24-hours post-CPB	Other (non-serious) Adverse Events (reported by arm/group)

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Pulmonary Vascular Resistance	Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)	dyne*second/centimeter˄5	MEAN
SECONDARY	Plasma Endothelin-1	Baseline, 0, 6, 12 and 24 hours post-CPB	fmol/mL	MEAN
OTHER_PRE_SPECIFIED	Sitaxsentan Levels	0, 6, 12 and 24 hours post-CPB	microg/mL	MEAN
OTHER_PRE_SPECIFIED	Number of Other Adverse Events By Type	up to 24-hours post-CPB	events	NUMBER

Source ClinicalTrials.gov

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pulmonary Vascular Resistance	Vehicle	Baseline	153.8	Standard Deviation 19.9	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	1mg/kg ET-ARA	Baseline	213.0	Standard Deviation 65.3	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	2mg/kg ET-ARA	Baseline	174.6	Standard Deviation 28.4	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	Vehicle	0 hours post-CPB	123.5	Standard Deviation 20.7	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	1mg/kg ET-ARA	0 hours post-CPB	125.3	Standard Deviation 24.8	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	2mg/kg ET-ARA	0 hours post-CPB	175.8	Standard Deviation 26.6	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	Vehicle	6 hours post-CPB	138.7	Standard Deviation 28.0	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	1mg/kg ET-ARA	6 hours post-CPB	144.6	Standard Deviation 15.2	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	2mg/kg ET-ARA	6 hours post-CPB	132.7	Standard Deviation 17.6	dyne*second/centimeter˄5
Pulmonary Vascular Resistance	Vehicle	12 hours post-CPB	146.8	Standard Deviation 21.6	dyne*second/centimeter˄5

1 to 10 of 86Source ClinicalTrials.gov

See all 86 results by group

Participant flow45

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline	STARTED	Vehicle	10
Baseline	STARTED	ET-ARA 1mg/kg	9
Baseline	STARTED	ET-ARA 2mg/kg	10
Baseline	COMPLETED	Vehicle	10
Baseline	COMPLETED	ET-ARA 1mg/kg	9
Baseline	COMPLETED	ET-ARA 2mg/kg	10
Baseline	NOT COMPLETED	Vehicle	0
Baseline	NOT COMPLETED	ET-ARA 1mg/kg	0
Baseline	NOT COMPLETED	ET-ARA 2mg/kg	0
0.5 Hours After Cardiopulmonary Bypass	STARTED	Vehicle	10

1 to 10 of 45Source ClinicalTrials.gov

See all 45 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Death	Cardiac disorders	Vehicle	0	10	0
serious	Death	Cardiac disorders	ET-ARA 1mg/kg	2	9	2
serious	Death	Cardiac disorders	ET-ARA 2mg/kg	1	10	1
serious	Thrombo-embolic event	Blood and lymphatic system disorders	Vehicle	1	10	1
serious	Thrombo-embolic event	Blood and lymphatic system disorders	ET-ARA 1mg/kg	4	9	4
serious	Thrombo-embolic event	Blood and lymphatic system disorders	ET-ARA 2mg/kg	3	10	3
serious	Pulmonary/infection	Infections and infestations	Vehicle	4	10	4
serious	Pulmonary/infection	Infections and infestations	ET-ARA 1mg/kg	0	9	0
serious	Pulmonary/infection	Infections and infestations	ET-ARA 2mg/kg	2	10	2
serious	Gastrointestinal (ischemic bowel)	Gastrointestinal disorders	Vehicle	1	10	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vehicle
Total, all-cause mortality	ET-ARA 1mg/kg
Total, all-cause mortality	ET-ARA 2mg/kg
Total, other adverse events	Vehicle	0	0
Total, other adverse events	ET-ARA 1mg/kg	0	0
Total, other adverse events	ET-ARA 2mg/kg	0	0
Total, serious adverse events	Vehicle	6	10
Total, serious adverse events	ET-ARA 1mg/kg	6	9
Total, serious adverse events	ET-ARA 2mg/kg	6	10

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18824748	RESULT	PubMed
19049753	RESULT	PubMed
20074751	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00744211

GET https://conductscience.org/api/trials/v1/NCT00744211/results?page=2

API reference For AI assistants