Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
ORBITA
Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease
1 other identifier
interventional
230
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 31, 2014
CompletedFirst Posted
Study publicly available on registry
February 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
April 22, 2021
CompletedJanuary 22, 2024
January 1, 2024
3.7 years
January 31, 2014
March 26, 2021
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise Time on Treadmill
Measured in seconds on Modified Bruce exercise treadmill protocol
6 weeks
Study Arms (2)
Coronary angioplasty and optimum medical therapy
ACTIVE COMPARATORPercutaneous coronary intervention and optimal medical therapy
Sham procedure and optimum medical therapy
PLACEBO COMPARATORPlacebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy
Interventions
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Eligibility Criteria
You may qualify if:
- Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Volcano Corporationcollaborator
Study Sites (5)
East Sussex Healthcare NHS Trust
Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom
Basildon and Thurrock University Hospitals NHS Trust
Basildon, SS16 5NL, United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Trust
Bournemouth, BH7 7DW, United Kingdom
Royal Devon & Exeter Foundation Trust
Exeter, EX2 5DW, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Related Publications (7)
Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2.
PMID: 29103656RESULTRajkumar CA, Wereski R, Parsonage W, Cullen L, Khamis R, Foley M, Harrell FE Jr, Shun-Shin MJ, Mills NL, Al-Lamee RK. Association Between High-Sensitivity Cardiac Troponin, Myocardial Ischemia, and Revascularization in Stable Coronary Artery Disease. J Am Coll Cardiol. 2022 May 31;79(21):2185-2187. doi: 10.1016/j.jacc.2022.03.369. No abstract available.
PMID: 35618353DERIVEDRajkumar CA, Shun-Shin M, Seligman H, Ahmad Y, Warisawa T, Cook CM, Howard JP, Ganesananthan S, Amarin L, Khan C, Ahmed A, Nowbar A, Foley M, Assomull R, Keenan NG, Sehmi J, Keeble TR, Davies JR, Tang KH, Gerber R, Cole G, O'Kane P, Sharp ASP, Khamis R, Kanaganayagam G, Petraco R, Ruparelia N, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Aug;14(8):e009891. doi: 10.1161/CIRCINTERVENTIONS.120.009891. Epub 2021 Aug 3.
PMID: 34340523DERIVEDMcCreanor V, Nowbar A, Rajkumar C, Barnett AG, Francis D, Graves N, Boden WE, Weintraub WS, Al-Lamee R, Parsonage WA. Cost-effectiveness analysis of percutaneous coronary intervention for single-vessel coronary artery disease: an economic evaluation of the ORBITA trial. BMJ Open. 2021 Feb 9;11(2):e044054. doi: 10.1136/bmjopen-2020-044054.
PMID: 33563623DERIVEDFoley M, Rajkumar CA, Shun-Shin M, Ganesananthan S, Seligman H, Howard J, Nowbar AN, Keeble TR, Davies JR, Tang KH, Gerber R, O'Kane P, Sharp ASP, Petraco R, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Achieving Optimal Medical Therapy: Insights From the ORBITA Trial. J Am Heart Assoc. 2021 Feb 2;10(3):e017381. doi: 10.1161/JAHA.120.017381. Epub 2021 Jan 26.
PMID: 33496201DERIVEDAl-Lamee RK, Shun-Shin MJ, Howard JP, Nowbar AN, Rajkumar C, Thompson D, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik I, Bual N, Cook C, Ahmad Y, Seligman H, Sharp ASP, Gerber R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE Jr, Mayet J, Thom S, Davies JE, Francis DP. Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA. Circulation. 2019 Dec 10;140(24):1971-1980. doi: 10.1161/CIRCULATIONAHA.119.042918. Epub 2019 Nov 11.
PMID: 31707827DERIVEDAl-Lamee R, Howard JP, Shun-Shin MJ, Thompson D, Dehbi HM, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik IS, Cook C, Ahmad Y, Sharp ASP, Gerber R, Baker C, Kaprielian R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE, Mayet J, Thom SA, Davies JE, Francis DP. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Single-Vessel Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1780-1792. doi: 10.1161/CIRCULATIONAHA.118.033801.
PMID: 29789302DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rasha Al-Lamee
- Organization
- Imperial College London
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2014
First Posted
February 13, 2014
Study Start
December 1, 2013
Primary Completion
August 1, 2017
Study Completion
September 1, 2017
Last Updated
January 22, 2024
Results First Posted
April 22, 2021
Record last verified: 2024-01