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

January 18, 2024 updated by: Imperial College London

Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Basildon, United Kingdom, SS16 5NL
        • Basildon and Thurrock University Hospitals NHS Trust
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals NHS Trust
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Foundation Trust
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust
    • East Sussex
      • Saint Leonards-on-sea, East Sussex, United Kingdom, TN37 7RD
        • East Sussex Healthcare Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Coronary angioplasty and optimum medical therapy
Percutaneous coronary intervention and optimal medical therapy
Procedure: Coronary angioplasty
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Other Names:
  • Percutaneous coronary intervention
Placebo Comparator: Sham procedure and optimum medical therapy
Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy
Procedure: Coronary angioplasty
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Other Names:
  • Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Time on Treadmill
Time Frame: 6 weeks
Measured in seconds on Modified Bruce exercise treadmill protocol
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Volcano Corporation

Investigators

  • Principal Investigator: Justin E Davies, MRCP, PhD, Imperial College London
  • Study Chair: Darrel P Francis, MRCP, MD, Imperial College London
  • Study Director: Rasha K Al-Lamee, MRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimated)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORBITA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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