Ivabradine and Post-revascularisation Microcirculatory Dysfunction

NCT02507050 | Withdrawn Phase 4 DMC

• 1 other identifier: 1060
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test whether, in patients with angina and flow limiting epicardial coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will reduce post percutaneous coronary intervention induced microvascular dysfunction.

Conditions

Coronary Artery Disease; Angina

Keywords

Ivabradine; Microvascular dysfunction; PCI; Procedural related myocardial injury; IMR; Index of Microvascular Resistance

Outcome Measures

Primary Outcomes (1)

• IMR (Index of Microvascular Resistance)

  Invasive marker of microvascular dysfunction

  Immediately after PCI

Secondary Outcomes (4)

• Peri-procedural Troponin Release

  3 hours after PCI

• CFI pre-revascularisation

  Immediately prior to PCI

• Symptomatic Improvement (Seattle Angina Questionnaire)

  18 weeks

• Coronary Flow Reserve

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Patients randomised to stop beta blockers and start Ivabradine. Initial dose of 5mg BD, titrated to 7.5mg BD if possible.

Drug: Ivabradine

Standard therapy

NO INTERVENTION

Bisoprolol given as standard beta blocker treatment i.e. Bisoprolol (maximum dose 10mg OD).

Interventions

Ivabradine DRUG

To start Ivabradine 6 weeks prior to PCI.

Also known as: Procoralan

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of Angina Pectoris
• Angiographic evidence of epicardial coronary artery stenosis referred for PCI
• Flow limiting lesion (Fractional Flow Reserve ≤0.80) in one of following locations (as defined in SYNTAX trial89):
• Proximal or mid left anterior descending artery (LAD)
• Proximal or mid dominant right coronary artery (RCA)
• Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel
• Existing beta blocker prescription
• Echocardiogram performed within preceding 12 months
• Patient consent

You may not qualify if:

• 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)
• FFR\>0.80 in target vessel at time of procedure
• Requirement for Multi-vessel intervention in a single procedure
• Any chronic total occlusion (100% epicardial occlusion) on angiography
• Distal coronary artery stenosis or that affecting non-dominant RCA
• Any rhythm other than sinus rhythm
• Sick sinus syndrome or high grade atrio-ventricular block
• Permanent Pacemaker in situ
• Congenital QT Syndrome
• Intolerance or allergy to beta-blockers
• Intolerance to Ivabradine
• Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia
• Concurrent required use of rate-limiting drugs other than beta-blockers
• The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control
• Contraindication to Magnetic Resonance Imaging or IV adenosine

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aleem Khand, MBChB MD

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

GB (1)