Does allopurinol (a xanthine oxidase inhibitor) have clinically useful anti-ischaemic effects in angina pectoris? - A randomised, double-blind, placebo-controlled trial

Phase 1

Conditions: Angina Pectoris
MedDRA version: 8.1Level: LLTClassification code 10002383Term: Angina pectoris

Registration Number: EUCTR2006-004611-21-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients who fulfill all of the followings:
1) age between 30 and 85 years
2) documented coronary artery disease on coronary angiography
3) angina pectoris for > 2 months
4) stable anti-anginal therapy for > 1 month
5) 2 positive exercise treadmill tests for ischaemia, done within a 2 week period and the time to ST depression on the second exercise test must be within 15% of the first test

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

Patients will be excluded if they:
1) do not fulfill any of the inclusion criteria
2) have heart failure or left ventricular systolic dysfunction (LV ejection fraction < 45% or LV fraction shortening < 25%)
3) had a myocardial infarction or acute coronary syndrom within the last 2 months
4) have ST abnormalities making it difficult to interprete their ECGs (including patients on digoxin)
5) have significant renal impairment (creatinine > 180)
6) have gout and already on allopurinol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to investigate if allopurinol (a xanthine oxidase inhibitor) has a clinically useful anti-ischaemic effects in patients with angina pectoris. This will primarily be assessed by the exercise treadmill test using a standard full Bruce protocoal. Patients will also be asked to record the number of angina attacks per week and their GTN consumption. ;Secondary Objective: ;Primary end point(s): This will be assessed using exercise treadmill test with the primary outcome measure being the time to 0.1mv ST depression.

Secondary Outcome Measures