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Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification 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 TypeStudy DesignPhaseEnrollmentStart DateEnd 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

FacilityAddressContactPhoneEmailStatus
University Hospital Birmingham Birmingham West Midlands B15 2TH United Kingdom - - - -
Brighton & Sussex University Hospitals NHS Trust Brighton West Sussex BN2 5BE United Kingdom - - - -

Intervention

TypeInterventionDescription
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

TypeMeasureTime FrameSafety 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

GenderMinimum AgeMaximum AgeHealthy 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.