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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Coronary angioplasty
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: Optimal 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02062593

Contacts
Contact: Rasha Al-Lamee r.al-lamee13@imperial.ac.uk

Locations
United Kingdom
Basildon and Thurrock University Hospitals NHS Trust Recruiting
Basildon, United Kingdom, SS16 5NL
Contact: Kare Tang, FRCP       kare.tang@btuh.nhs.uk   
Principal Investigator: Kare Tang, FRCP         
Sub-Investigator: John Davies, MRCP PhD         
Royal Devon & Exeter Foundation Trust Not yet recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Andrew Sharp, MRCP MD       andrewsharp@doctors.org.uk   
Principal Investigator: Andrew Sharp, MRCP MD         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Rasha Al-Lamee, MRCP       r.al-lamee13@imperial.ac.uk   
Principal Investigator: Justin E Davies, MRCP PhD         
Sponsors and Collaborators
Imperial College London
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
  More Information

Additional Information:
No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02062593     History of Changes
Other Study ID Numbers: ORBITA-1
Study First Received: January 31, 2014
Last Updated: March 25, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 29, 2014