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

Imperial College London

Status: Completed

Conditions: Stable Angina

Treatments: Procedure: Coronary angioplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02062593

ORBITA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups, including a placebo group

Coronary angioplasty and optimum medical therapy

Active Comparator group

Description:

Percutaneous coronary intervention and optimal medical therapy

Treatment:

Procedure: Coronary angioplasty

Sham procedure and optimum medical therapy

Placebo Comparator group

Description:

Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy

Treatment:

Procedure: Coronary angioplasty