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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Imperial College London
Volcano Corporation
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: January 31, 2014
Last updated: February 8, 2017
Last verified: February 2017
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.

Condition Intervention
Stable Angina
Procedure: Coronary angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Exercise time on treadmill [ Time Frame: 6 weeks ]

Estimated Enrollment: 200
Actual Study Start Date: December 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Percutaneous coronary intervention

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02062593

Contact: Rasha Al-Lamee

United Kingdom
East Sussex Healthcare NHS Trust Recruiting
Saint Leonards-on-sea, East Sussex, United Kingdom, TN37 7RD
Contact: Robert Gerber, MRCP PhD    01424755255 ext 8127   
Principal Investigator: Robert Gerber, MRCP PhD         
Basildon and Thurrock University Hospitals NHS Trust Recruiting
Basildon, United Kingdom, SS16 5NL
Contact: Kare Tang, FRCP   
Principal Investigator: Kare Tang, FRCP         
Sub-Investigator: John Davies, MRCP PhD         
The Royal Bournemouth and Christchurch Hospitals NHS Trust Recruiting
Bournemouth, United Kingdom, BH7 7DW
Contact: Suneel Talwar, MRCP MD    01202704514   
Principal Investigator: Suneel Talwar, MRCP MD         
Royal Devon & Exeter Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Andrew Sharp, MRCP MD   
Principal Investigator: Andrew Sharp, MRCP MD         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Rasha Al-Lamee, MRCP   
Principal Investigator: Justin E Davies, MRCP PhD         
Sponsors and Collaborators
Imperial College London
Volcano Corporation
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
  More Information

Responsible Party: Imperial College London Identifier: NCT02062593     History of Changes
Other Study ID Numbers: ORBITA-1
Study First Received: January 31, 2014
Last Updated: February 8, 2017

Keywords provided by Imperial College London:
Stable angina
Percutaneous coronary intervention
Optimal medical therapy

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms processed this record on May 25, 2017