Metabolic Support with Perhexilene to Protect Myocardium undergoing Coronary Artery Surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003164-62-GB

Enrollment

300

Registered

2006-10-16

Start date

2007-01-22

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing coronary artery bypass surgery

Interventions

Trade Name: Pexsig Product Name: Pexsig Pharmaceutical Form: Tablet INN or Proposed INN: Perhexilene CAS Number: 6724-53-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult non-diabetic patients undergoing first time coronary artery bypass surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy, renal impairment (serum creatinine> 200µmol/L), diabetes mellitus, procedures involving other heart valves and surgery for catastrophic event.

Design outcomes

Primary

Measure	Time frame
Main Objective: During cardiac surgery a cross clamp is placed on the ascending aorta distal to the origin of the coronary arteries which results in complete cessation of blood flow through the myocardium. Perhexiline maleate is an anti-anginal drug that potently inhibits the mitochondrial FFA uptake enzymes carnitine-palmitoyl-transferase-1 and -2, thus shifting muscle substrate utilisation from FFA to glucose. We hypothesise that preoperative loading with perhexiline in patients undergoing cardiac surgery on cardiopulmonary bypass will improve myocardial protection during surgery. ;Secondary Objective: The secondary hypothesis is that enhances in myocardial protection are through improved energy conservation (high energy phosphates). ;Primary end point(s): The primary endpoint will be the incidence of low cardiac output syndrome (LCOS) after surgery. This is an indicator of inadequate myocardial protection and for the purpose of this study LCOS is defined as hypotension (mean arterial pressure 75 bpm) where systolic blood pressure 60 minutes to maintain such a clinical picture	—

Measure

Time frame

Main Objective: During cardiac surgery a cross clamp is placed on the ascending aorta distal to the origin of the coronary arteries which results in complete cessation of blood flow through the myocardium. Perhexiline maleate is an anti-anginal drug that potently inhibits the mitochondrial FFA uptake enzymes carnitine-palmitoyl-transferase-1 and -2, thus shifting muscle substrate utilisation from FFA to glucose. We hypothesise that preoperative loading with perhexiline in patients undergoing cardiac surgery on cardiopulmonary bypass will improve myocardial protection during surgery. ;Secondary Objective: The secondary hypothesis is that enhances in myocardial protection are through improved energy conservation (high energy phosphates). ;Primary end point(s): The primary endpoint will be the incidence of low cardiac output syndrome (LCOS) after surgery. This is an indicator of inadequate myocardial protection and for the purpose of this study LCOS is defined as hypotension (mean arterial pressure 75 bpm) where systolic blood pressure 60 minutes to maintain such a clinical picture

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026