A trial to investigate whether Ivabradine can reduce the amount of subtle heart damage that can be suffered during stent procedures.

• Conditions: Coronary Artery Disease/Angina; MedDRA version: 18.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: LLTClassification code 10011073Term: Coronary artery atheromaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: LLTClassification code 10002372Term: AnginaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: LLTClassification code 10003600Term: Atheroma coronary arterySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003260-37-GB
• Lead Sponsor: iverpool Heart and Chest Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.1.Symptoms of Angina Pectoris
2.Angiographic evidence of epicardial coronary artery stenosis referred for PCI
3.Flow limiting lesion (Fractional Flow Reserve =0.80) in one of following locations (as defined in SYNTAX trial):
a.Proximal or mid left anterior descending artery (LAD)
b.Proximal or mid dominant right coronary artery (RCA)
c.Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel
4.Existing beta blocker prescription
5.Echocardiogram performed within preceding 12 months
6.Patient consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.1.Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography)
2.FFR>0.80 in target vessel at time of procedure
3.Requirement for Multi-vessel intervention in a single procedure
4.Any chronic total occlusion (100% epicardial occlusion) on angiography
5.Distal coronary artery stenosis or that affecting non-dominant RCA
6.Heart Rate <60 bpm at inclusion (assessed by 12 lead ECG after minimum 10 minutes rest period)
7.Any rhythm other than sinus rhythm
8.Sick sinus syndrome or high grade atrio-ventricular block
9.Permanent Pacemaker in situ
10.Congenital QT Syndrome
11.Intolerance or allergy to beta-blockers
12.Intolerance to Ivabradine
13.Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia
14.Concurrent required use of rate-limiting drugs other than beta-blockers
15.The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control
16.Contraindication to Magnetic Resonance Imaging or IV adenosine
17.Severe impairment of renal function (eGFR<30ml/min)
18.Severe Liver Disease (Any worse than Grade A by Child-Pugh Classification)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified