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Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01653223
First received: July 26, 2012
Last updated: July 12, 2014
Last verified: July 2014

July 26, 2012
July 12, 2014
January 2013
December 2017   (final data collection date for primary outcome measure)
troponin [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: Yes ]
The investigator will measure the plasma troponin level in several time points before and after surgery in each patient.
Same as current
Complete list of historical versions of study NCT01653223 on ClinicalTrials.gov Archive Site
ejection fraction [ Time Frame: within two years ] [ Designated as safety issue: No ]
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6,12,18 and 24 months after surgery. The ejection fraction will be measured
Same as current
long term survival [ Time Frame: within two years ] [ Designated as safety issue: No ]
Each patient will be followed up and observed survival time.
Same as current
 
Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. We recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. We further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Congenital Heart Disease
  • Heart Valve Disease
Drug: simvastatin

In short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days.

In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months.

Other Name: simcor
  • No Intervention: control
    untreated
  • Experimental: short statin
    Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 7 days postoperatively.
    Intervention: Drug: simvastatin
  • Experimental: long statin
    Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 6 months postoperatively.
    Intervention: Drug: simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
369
December 2019
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • More than 18-year-old,
  • Congenital heart disease(not complex),
  • Isolated heart valve disease,

Exclusion Criteria:

  • Coronary artery disease
  • Allergy for statins
  • Poor liver function,Hepatitis
  • Gestation women and Breast-feeding women
  • Hypercholesterolemia
Both
10 Years and older
No
Contact: Jing-song Ou, MD, PhD 8620-87755766 ext 8238 oujs2000@yahoo.com
Contact: Zhi-ping Wang, MD, PhD 8620-87755766 ext 8238
China
 
NCT01653223
statin2, 5010-2012001
Yes
Jing-song Ou, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP