A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina

NCT03742050 | Completed DMC

• 1 other identifier: 18SM4531
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 8

Brief Summary

ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. Follow-up will be at 12 weeks.

Conditions

Stable Angina

Keywords

Stable Angina

Outcome Measures

Primary Outcomes (1)

• Change in angina symptom score between groups

  12 weeks

Secondary Outcomes (7)

• Change in treadmill exercise time

  12 weeks

• Angina severity as assessed by Canadian Cardiovascular Society class

  12 weeks

• Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire

  12 weeks

• Quality of life as assessed with the EQ-5D-5L questionnaire

  12 weeks

• Change in dobutamine stress echocardiography score

  12 weeks

Study Arms (2)

Percutaneous coronary intervention

ACTIVE COMPARATOR

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Procedure: Percutaneous coronary intervention

Placebo percutaneous coronary intervention

PLACEBO COMPARATOR

Placebo percutaneous coronary intervention

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation

Also known as: Coronary angioplasty

Percutaneous coronary intervention; Placebo percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ORBITA-2 will enrol patients who meet all 3 of the following criteria:
• Angina or angina-equivalent symptoms
• Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis
• Evidence of ischaemia, arising from at least one of the following options:
• Positive dobutamine stress echocardiography
• Positive cardiac MRI perfusion scan
• Positive nuclear medicine myocardial perfusion scan
• Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram

You may not qualify if:

• Age younger than 18
• Age older than 85
• Recent acute coronary event
• Previous coronary artery bypass graft surgery
• Significant left main stem coronary disease
• Chronic total occlusion in the target vessel
• Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
• Contraindication to antiplatelet therapy
• Severe valvular disease
• Severe LV systolic impairment
• Severe respiratory disease
• Life expectancy less than 2 years, pregnancy, unable to consent

Sponsors & Collaborators

• Imperial College London: lead
• Basildon and Thurrock Hospitals NHS FoundationTrust: collaborator

Study Sites (8)

Basildon and Thurrock Hospitals NHS Foundation Trust

Basildon, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH77DW, United Kingdom

Location

Wycombe Hospital

High Wycombe, HP11 2TT, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

Harefield Hospital

Uxbridge, UB9 6JH, United Kingdom

Location

Related Publications (4)

• Simader FA, Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Chotai S, Chiew K, Naderi Z, Davies JR, Keeble TR, O'Kane PD, Haworth P, Nijjer SS, Howard JP, Cole G, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK; ORBITA-2 Investigators. Association Between Age and PCI Effectiveness in Stable CAD: Secondary Analysis of ORBITA-2. J Am Coll Cardiol. 2026 Jan 27;87(3):253-265. doi: 10.1016/j.jacc.2025.10.086.

  PMID: 41603507 DERIVED

• Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader F, Chotai S, Seligman H, Macierzanka K, Davies JR, Keeble TR, O'Kane P, Haworth P, Routledge H, Kotecha T, Clesham G, Williams R, Din J, Nijjer SS, Curzen N, Sinha M, Petraco R, Spratt J, Sen S, Cole GD, Harrell FE Jr, Howard JP, Francis DP, Shun-Shin MJ, Al-Lamee R; ORBITA-2 Investigators. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease. Circulation. 2025 Jan 21;151(3):202-214. doi: 10.1161/CIRCULATIONAHA.124.072281. Epub 2024 Oct 27.

  PMID: 39462291 DERIVED

• Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Nowbar AN, Simader FA, Davies JR, O'Kane PD, Haworth P, Routledge H, Kotecha T, Gamma R, Clesham G, Williams R, Din J, Nijjer SS, Curzen N, Ruparelia N, Sinha M, Dungu JN, Ganesananthan S, Khamis R, Mughal L, Kinnaird T, Petraco R, Spratt JC, Sen S, Sehmi J, Collier DJ, Sohaib A, Keeble TR, Cole GD, Howard JP, Francis DP, Shun-Shin MJ, Al-Lamee RK; ORBITA-2 Investigators. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. N Engl J Med. 2023 Dec 21;389(25):2319-2330. doi: 10.1056/NEJMoa2310610. Epub 2023 Nov 11.

  PMID: 38015442 DERIVED

• Nowbar AN, Rajkumar C, Foley M, Ahmed-Jushuf F, Howard JP, Seligman H, Petraco R, Sen S, Nijjer SS, Shun-Shin MJ, Keeble TR, Sohaib A, Collier D, McVeigh P, Harrell FE, Francis DP, Al-Lamee RK. A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial. EuroIntervention. 2022 Apr 22;17(18):1490-1497. doi: 10.4244/EIJ-D-21-00649.

  PMID: 35156616 DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

Percutaneous Coronary Intervention; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Angioplasty; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Darrel Francis, MRCP

  Imperial College London

  STUDY CHAIR

• Christopher A Rajkumar

  Imperial College London

  STUDY DIRECTOR

• Rasha Al-Lamee

  Imperial College London

  PRINCIPAL INVESTIGATOR

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: November 13, 2018
• First Posted: November 15, 2018
• Study Start: November 12, 2018
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8)