Trial Outcomes & Findings for Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery (NCT NCT01096875)

NCT ID: NCT01096875

Last Updated: 2014-07-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Postoperative 6th hours
• Results posted on: 2014-07-09

Participant Flow

Participant milestones

Measure	Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Baseline characteristics by cohort

Measure	Atorvastatin n=30 Participants Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=30 Participants Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	60.8 years STANDARD_DEVIATION 8.6 • n=5 Participants	62.2 years STANDARD_DEVIATION 8.1 • n=7 Participants	61.6 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Turkey	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative 6th hours

Outcome measures

Measure	Atorvastatin n=30 Participants Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=29 Participants Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
Endothelial Progenitor Cells (EPCs) Count (Cells/µl)	5.00 cells/µl Standard Error 0.06	2.19 cells/µl Standard Error 0.06

SECONDARY outcome

Timeframe: Change between statin and placebo groups at 30 days postoperatively

Outcome measures

Measure	Atorvastatin n=30 Participants Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=29 Participants Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively	54.3 percentage of LVEF Standard Deviation 7.5	53.2 percentage of LVEF Standard Deviation 8.7

SECONDARY outcome

Timeframe: Postoperative 6th hours

Outcome measures

Measure	Atorvastatin n=30 Participants Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=29 Participants Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
High Sensitive C-reactive Protein (hsCRP mg/L)	72.9 mg/L Standard Error 0.6	96.0 mg/L Standard Error 0.7

SECONDARY outcome

Timeframe: 5 days postoperatively

Outcome measures

Measure	Atorvastatin n=30 Participants Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=29 Participants Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
High Sensitive C-reactive Protein (hsCRP mg/L)	4.3 mg/L Standard Error 0.2	11.4 mg/L Standard Error 0.8

Adverse Events

Atorvastatin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atorvastatin n=30 participants at risk Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin : 40mg/day once daily for two weeks prior to surgery	Placebo n=29 participants at risk Atorvastatin like pill Placebo : 1tb/day once daily for two weeks prior to surgery
Cardiac disorders Low cardiac output	3.3% 1/30 • 30 days postoperatively	0.00% 0/29 • 30 days postoperatively
Cardiac disorders Myocardial infarction	0.00% 0/30 • 30 days postoperatively	3.4% 1/29 • 30 days postoperatively
Cardiac disorders Ventricular arrhythmia	0.00% 0/30 • 30 days postoperatively	3.4% 1/29 • 30 days postoperatively

Other adverse events

Adverse event data not reported

Additional Information

Prof. A. Ruchan Akar MD., FRCS(CTh).

Ankara University Medical Faculty, Department of Cardiovascular Surgery

Phone: +90 533 646 06 84

Email: akarruchan@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place