Trial · NCT00607672

The RAS, Fibrinolysis and Cardiopulmonary Bypass

NCT00607672, Phase 4, Completed, Vanderbilt University; results first posted 2012-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The RAS, Fibrinolysis and Cardiopulmonary Bypass. Trials, record NCT00607672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00607672

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Trial

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

Title: The RAS, Fibrinolysis and Cardiopulmonary Bypass
NCT number: NCT00607672
Status: Completed
Phases: Phase 4
Enrollment: 111 participants, actual
Lead sponsor: Vanderbilt University
Conditions: Coronary Artery Disease, Angiotensin Converting Enzyme, Angiotensin Receptor Blockers, Cardiopulmonary Bypass, Fibrinolysis, Inflammation
Interventions: Placebo, Ramipril, Candesartan
First posted: 2008-02-06
Last updated: 2012-10-10
Results first posted: 2012-10-10
Limitations and caveats: We cannot exclude the possibility that our results may have been different if we studied a homogenous surgery population.

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Tissue-type Plasminogen Activator (t-PA) Antigen Response	From the start of surgery until postoperative day 2	To compare the effects of angiotensin II type I (AT1) receptor antagonism or angiotensin-converting enzyme (ACE) inhibition versus placebo on the fibrinolytic responses to cardiopulmonary bypass (CPB) as measured by t-PA antigen response
Primary	Plasminogen Activator Inhibitor-1 (PAI-1) Response	From the start of surgery until postoperative day 2	To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the fibrinolytic responses to CPB as measured by PAI-1 response
Primary	Interleukin-6 (IL-6) Response	From the start of surgery until postoperative day 2	To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-6
Primary	Interleukin-8 (IL-8) Response	From the start of surgery until postoperative day 2	To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-8
Primary	Interleukin-10 (IL-10) Response	From the start of surgery until postoperative day 2	To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by the IL-10 response
Secondary	Blood Loss	First 24 hours after arrival in the intensive care unit	Blood loss over 24 hours as measured by chest tube output
Secondary	Re-exploration for Bleeding	From arrival in intensive care unit until discharge from hospital	The percentage of patients that were taken back to the operating room for re-exploration because of bleeding
Secondary	Blood Product Transfusion Requirement	From the start of surgery until discharge from hospital	Percentage of patients that received blood product transfusion
Secondary	Vasopressor Drug Use	From the end of cardiopulmonary bypass until arrival in intensive care unit
Secondary	New Onset Atrial Fibrillation	From arrival in intensive care unit until discharge from hospital	New onset atrial fibrillation based on electrocardiogram (ECG) rhythm strips with a duration longer than 10 seconds

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Tissue-type Plasminogen Activator (t-PA) Antigen Response	From the start of surgery until postoperative day 2	ng/mL	MEAN
PRIMARY	Plasminogen Activator Inhibitor-1 (PAI-1) Response	From the start of surgery until postoperative day 2	ng/mL	MEAN
SECONDARY	Blood Loss	First 24 hours after arrival in the intensive care unit	mL	MEAN
SECONDARY	Re-exploration for Bleeding	From arrival in intensive care unit until discharge from hospital	percentage of patients	NUMBER
SECONDARY	Blood Product Transfusion Requirement	From the start of surgery until discharge from hospital	percentage of patients	NUMBER
SECONDARY	Vasopressor Drug Use	From the end of cardiopulmonary bypass until arrival in intensive care unit	percentage of patients	NUMBER
SECONDARY	New Onset Atrial Fibrillation	From arrival in intensive care unit until discharge from hospital	percentage of patients	NUMBER
SECONDARY	Acute Kidney Injury	From the start of surgery until postoperative day 3	percentage of patients	NUMBER
SECONDARY	Stroke	From arrival in intensive care unit until discharge from hospital	percentage of patients	NUMBER
SECONDARY	Length of Hospital Stay	From the start of surgery until discharge from hospital	days	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group108

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

Outcome	Group	Category	Value	Spread	Units
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Placebo	Pre CPB	14.36	Standard Error 1.45	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Ramipril (ACEI)	Pre CPB	14.05	Standard Error 1.86	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Candesartan (ARB)	Pre CPB	11.97	Standard Error 1.03	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Placebo	60min of CPB	27.65	Standard Error 3.39	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Ramipril (ACEI)	60min of CPB	36.67	Standard Error 7.26	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Candesartan (ARB)	60min of CPB	24.89	Standard Error 2.96	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Placebo	Post surgery	34.56	Standard Error 3.35	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Ramipril (ACEI)	Post surgery	41.11	Standard Error 3.37	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Candesartan (ARB)	Post surgery	31.47	Standard Error 2.61	ng/mL
Tissue-type Plasminogen Activator (t-PA) Antigen Response	Placebo	Postoperative day 1	20.25	Standard Error 2.03	ng/mL

1 to 10 of 108Source ClinicalTrials.gov

See all 108 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	32
Overall Study	STARTED	Ramipril (ACEI)	27
Overall Study	STARTED	Candesartan (ARB)	27
Overall Study	COMPLETED	Placebo	28
Overall Study	COMPLETED	Ramipril (ACEI)	24
Overall Study	COMPLETED	Candesartan (ARB)	22
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Ramipril (ACEI)	3
Overall Study	NOT COMPLETED	Candesartan (ARB)	5

Source ClinicalTrials.gov

Adverse events15

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
other	Acute kidney injury	Renal and urinary disorders	Placebo	8	28
other	Acute kidney injury	Renal and urinary disorders	Ramipril (ACEI)	5	24
other	Acute kidney injury	Renal and urinary disorders	Candesartan (ARB)	8	22
other	New onset atrial fibrillation	Cardiac disorders	Placebo	5	28
other	New onset atrial fibrillation	Cardiac disorders	Ramipril (ACEI)	4	24
other	New onset atrial fibrillation	Cardiac disorders	Candesartan (ARB)	6	22
other	Re-exploration	General disorders	Placebo	1	28
other	Re-exploration	General disorders	Ramipril (ACEI)	2	24
other	Re-exploration	General disorders	Candesartan (ARB)	1	22
serious	Stroke	Nervous system disorders	Placebo	2	28

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Ramipril (ACEI)
Total, all-cause mortality	Candesartan (ARB)
Total, other adverse events	Placebo	11	28
Total, other adverse events	Ramipril (ACEI)	10	24
Total, other adverse events	Candesartan (ARB)	12	22
Total, serious adverse events	Placebo	2	28
Total, serious adverse events	Ramipril (ACEI)	1	24
Total, serious adverse events	Candesartan (ARB)	2	22

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22549281	RESULT	PubMed
26494370	DERIVED	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.

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