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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
Sponsor:
Collaborator:
Volcano Corporation
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02062593
First received: January 31, 2014
Last updated: February 8, 2017
Last verified: February 2017
January 31, 2014
February 8, 2017
December 2013
August 2017   (Final data collection date for primary outcome measure)
Exercise time on treadmill [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT02062593 on ClinicalTrials.gov Archive Site
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Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
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.
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.
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Stable Angina
Procedure: Coronary angioplasty
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Other Name: Percutaneous coronary intervention
  • Active Comparator: Coronary angioplasty and optimum medical therapy
    Percutaneous coronary intervention and optimal medical therapy
    Intervention: Procedure: Coronary angioplasty
  • Placebo Comparator: Sham procedure and optimum medical therapy
    Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy
    Intervention: Procedure: Coronary angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact: Rasha Al-Lamee r.al-lamee13@imperial.ac.uk
United Kingdom
 
 
NCT02062593
ORBITA-1
Yes
Not Provided
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Imperial College London
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
Imperial College London
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP