A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
NCT ID: NCT03742050
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
439 participants
INTERVENTIONAL
2018-11-12
2023-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Placebo percutaneous coronary intervention
Placebo percutaneous coronary intervention
Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Interventions
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Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Angina or angina-equivalent symptoms
2. 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
3. Evidence of ischaemia, arising from at least one of the following options:
1. Positive dobutamine stress echocardiography
2. Positive cardiac MRI perfusion scan
3. Positive nuclear medicine myocardial perfusion scan
4. Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram
Exclusion Criteria
2. Age older than 85
3. Recent acute coronary event
4. Previous coronary artery bypass graft surgery
5. Significant left main stem coronary disease
6. Chronic total occlusion in the target vessel
7. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
8. Contraindication to antiplatelet therapy
9. Severe valvular disease
10. Severe LV systolic impairment
11. Severe respiratory disease
12. Life expectancy less than 2 years, pregnancy, unable to consent
18 Years
85 Years
ALL
No
Sponsors
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Basildon and Thurrock Hospitals NHS FoundationTrust
UNKNOWN
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Darrel Francis, MRCP
Role: STUDY_CHAIR
Imperial College London
Christopher A Rajkumar
Role: STUDY_DIRECTOR
Imperial College London
Rasha Al-Lamee
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Wycombe Hospital
High Wycombe, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Harefield Hospital
Uxbridge, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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18SM4531
Identifier Type: -
Identifier Source: org_study_id
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