Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Reperfusion Injury Cardiac Output, Low

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Perhexiline

Pre-operative administration of Perhexiline tablets according to dosing schedule

Group Type EXPERIMENTAL

Perhexiline

Intervention Type DRUG

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Placebo

Pre-operative administration of placebo tablets according to dosing schedule

Group Type PLACEBO_COMPARATOR

Placebo marked PEXSIG

Intervention Type DRUG

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Interventions

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Perhexiline

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Intervention Type DRUG

Placebo marked PEXSIG

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Intervention Type DRUG

Other Intervention Names

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PEXSIG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No