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

NCT ID: NCT02062593

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-09-30

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.

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.

Conditions

Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Coronary angioplasty and optimum medical therapy

Percutaneous coronary intervention and optimal medical therapy

Group Type: ACTIVE_COMPARATOR

Coronary angioplasty

Intervention Type: PROCEDURE

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Sham procedure and optimum medical therapy

Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy

Group Type: PLACEBO_COMPARATOR

Coronary angioplasty

Intervention Type: PROCEDURE

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Interventions

Coronary angioplasty

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous coronary intervention

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin E Davies, MRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Darrel P Francis, MRCP, MD

Role: STUDY_CHAIR

Imperial College London

Rasha K Al-Lamee, MRCP

Role: STUDY_DIRECTOR

Imperial College London

Locations

East Sussex Healthcare NHS Trust

Saint Leonards-on-Sea, East Sussex, United Kingdom

Basildon and Thurrock University Hospitals NHS Trust

Basildon, , United Kingdom

The Royal Bournemouth and Christchurch Hospitals NHS Trust

Bournemouth, , United Kingdom

Royal Devon & Exeter Foundation Trust

Exeter, , United Kingdom

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 29103656 (View on PubMed)

Rajkumar 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.

Reference Type: DERIVED

PMID: 35618353 (View on PubMed)

Rajkumar 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.

Reference Type: DERIVED

PMID: 34340523 (View on PubMed)

McCreanor 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.

Reference Type: DERIVED

PMID: 33563623 (View on PubMed)

Foley 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.

Reference Type: DERIVED

PMID: 33496201 (View on PubMed)

Al-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.

Reference Type: DERIVED

PMID: 31707827 (View on PubMed)

Al-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.

Reference Type: DERIVED

PMID: 29789302 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ORBITA-1

Identifier Type: -

Identifier Source: org_study_id