Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Completed	Myocardial Reperfusion Injury; Cardiac Output; Low	University Hospital Birmingham Other collaborator(s): University of Birmingham; Brighton and Sussex University Hospitals NHS Trust; British Heart Foundation	February 17, 2009	May 19, 2010	May 2010

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment	Phase 2/Phase 3	290	February 2007	-

Locations

Facility	Address	Contact	Phone	Email	Status
University Hospital Birmingham	Birmingham West Midlands B15 2TH United Kingdom	-	-	-	-
Brighton & Sussex University Hospitals NHS Trust	Brighton West Sussex BN2 5BE United Kingdom	-	-	-	-

Intervention

Type	Intervention	Description
Drug	Perhexiline	Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Drug	Placebo marked PEXSIG	Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Outcome

Type	Measure	Time Frame	Safety Issue
Primary	Incidence of Low Cardiac Output Syndrome	6 hours post-removal of aortic X-clamp	No
Secondary	Increase in Cardiac index of greater than or equal to 0.3 L/min/m2	6 hours post-removal of aortic X-clamp	No
Secondary	Incidence of inotropes use according to protocol	6 and 12 hours post-removal of aortic X-clamp	No
Secondary	Peak and total release of Troponin	6, 12 and 24 hours post-release of aortic X-clamp	No

Official Title

Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

Eligibility

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Both	-	N/A	No

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

Citations

PMID 16399292: Quinn DW, Pagano D, Bonser RS, Rooney SJ, Graham TR, Wilson IC, Keogh BE, Townend JN, Lewis ME, Nightingale P; Study Investigators. Improved myocardial protection during coronary artery surgery with glucose-insulin-potassium: a randomized controlled trial. J Thorac Cardiovasc Surg. 2006 Jan;131(1):34-42.

PMID 16820580: Ranasinghe AM, Quinn DW, Pagano D, Edwards N, Faroqui M, Graham TR, Keogh BE, Mascaro J, Riddington DW, Rooney SJ, Townend JN, Wilson IC, Bonser RS. Glucose-insulin-potassium and tri-iodothyronine individually improve hemodynamic performance and are associated with reduced troponin I release after on-pump coronary artery bypass grafting. Circulation. 2006 Jul 4;114(1 Suppl):I245-50.

PMID 17445089: Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. Review.