Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

Not Applicable

Completed

• Conditions: Stable Angina
• Interventions: Procedure: Coronary angioplasty

• Registration Number: NCT02062593
• Lead Sponsor: Imperial College London

Brief Summary

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

Detailed Description

The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Results First Submitted: 2021-03-26
• Results First Submitted QC: 2021-03-26
• Results First Posted: 2021-04-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation

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Exclusion Criteria

• Acute coronary syndrome
• Previous coronary artery bypass graft surgery
• Left main stem disease
• Contraindications to PCI or drug-eluting stent (DES) implantation
• Heavily calcified or tortuous vessels
• Chronic total occlusion in target vessel
• Life expectancy <2yr
• Pregnancy
• Age <18yr or >85yr
• Angiographic stenosis ≥ 50% in non-target vessel
• Inability to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary angioplasty and optimum medical therapy	Coronary angioplasty	Percutaneous coronary intervention and optimal medical therapy
Sham procedure and optimum medical therapy	Coronary angioplasty	Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy

Primary Outcome Measures

Name	Time	Method
Exercise Time on Treadmill	6 weeks	Measured in seconds on Modified Bruce exercise treadmill protocol

Trial Locations

Locations (5)

East Sussex Healthcare NHS Trust; 🇬🇧 Saint Leonards-on-sea, East Sussex, United Kingdom

Basildon and Thurrock University Hospitals NHS Trust; 🇬🇧 Basildon, United Kingdom

Royal Devon & Exeter Foundation Trust; 🇬🇧 Exeter, United Kingdom

The Royal Bournemouth and Christchurch Hospitals NHS Trust; 🇬🇧 Bournemouth, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom