Comparison of Coronary Angioplasty and Optimum Medical Therapy Versus Optimal Medical Therapy in the Stable Angina (ORBITA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: March 25, 2014
Last verified: December 2013

January 31, 2014
March 25, 2014
December 2013
December 2015   (final data collection date for primary outcome measure)
Exercise time on treadmill [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02062593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Coronary Angioplasty and Optimum Medical Therapy Versus Optimal Medical Therapy in the 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. Three 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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Percutaneous coronary intervention and optimal medical therapy
    Intervention: Procedure: Coronary angioplasty
  • Placebo Comparator: Optimal 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
300
December 2016
December 2015   (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
Both
18 Years to 85 Years
No
Contact: Rasha Al-Lamee r.al-lamee13@imperial.ac.uk
United Kingdom
 
NCT02062593
ORBITA-1
Yes
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
December 2013

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