Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery (CASPER)

This study has been completed.
Sponsor:
Collaborators:
University of Birmingham
Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00845364
First received: February 17, 2009
Last updated: May 19, 2010
Last verified: May 2010

February 17, 2009
May 19, 2010
February 2007
April 2010   (final data collection date for primary outcome measure)
Incidence of Low Cardiac Output Syndrome [ Time Frame: 6 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00845364 on ClinicalTrials.gov Archive Site
  • Increase in Cardiac index of greater than or equal to 0.3 L/min/m2 [ Time Frame: 6 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
  • Incidence of inotropes use according to protocol [ Time Frame: 6 and 12 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
  • Peak and total release of Troponin [ Time Frame: 6, 12 and 24 hours post-release of aortic X-clamp ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery
Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Reperfusion Injury
  • Cardiac Output, Low
  • Drug: Perhexiline
    Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
    Other Name: PEXSIG
  • Drug: Placebo marked PEXSIG
    Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
  • Experimental: Perhexiline
    Pre-operative administration of Perhexiline tablets according to dosing schedule
    Intervention: Drug: Perhexiline
  • Placebo Comparator: Placebo
    Pre-operative administration of placebo tablets according to dosing schedule
    Intervention: Drug: Placebo marked PEXSIG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult
  • First-time
  • Isolated coronary artery bypass surgery

Exclusion Criteria:

  • Diabetes Mellitus
  • Renal impairment with Creatinine greater than or equal to 200micromol/L
  • Atrial fibrillation
  • Amiodarone therapy, recent (in last month) or current
  • Hepatic impairment, significant preoperative
  • Peripheral neuropathy
  • Pregnancy or breast-feeding
  • Emergency surgery or required on clinical grounds within 5 days of referral
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00845364
RRK3217, Eudract 2006-003164-62, REC 06/Q0104/141, BHF PG/06/044/20703
Yes
Mr Domenico Pagano, University Hospital Birmingham
University Hospital Birmingham
  • University of Birmingham
  • Brighton and Sussex University Hospitals NHS Trust
  • British Heart Foundation
Principal Investigator: Domeinco Pagano, MD FRCS University Hospital Birmingham
University Hospital Birmingham
May 2010

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