Stable AnginaORBITA-2NCT03742050
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
A study testing Percutaneous coronary intervention in people with Stable Angina, run by Imperial College London at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 12 Nov 2018to 6 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon
Royal Bournemouth Hospital
Bournemouth, BH77DW
Wycombe Hospital
High Wycombe, HP11 2TT
Imperial College Healthcare NHS Trust
London, W12 0HS
Royal Free Hospital
London
Queen Alexandra Hospital
Portsmouth
Royal Berkshire NHS Foundation Trust
Reading
Harefield Hospital
Uxbridge, UB9 6JH
About this study
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
- Being tested
- Percutaneous coronary intervention
- Keywords
- Stable Angina
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called Coronary angioplasty
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Percutaneous coronary intervention with drug-eluting stents and modern techniques Receives: Procedure: Percutaneous coronary intervention |
| Placebo percutaneous coronary intervention | Placebo comparator | Placebo percutaneous coronary intervention Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in angina symptom score between groups
Measured: 12 weeks
Secondary outcomes (7)
Change in treadmill exercise time
Measured: 12 weeks
Angina severity as assessed by Canadian Cardiovascular Society class
Measured: 12 weeks
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
Measured: 12 weeks
Quality of life as assessed with the EQ-5D-5L questionnaire
Measured: 12 weeks
Change in dobutamine stress echocardiography score
Measured: 12 weeks
Need for anti-anginal medication introduction and up-titration
Measured: 12 weeks
Admission for acute coronary syndrome or unscheduled coronary angiography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start12 Nov 2018
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Basildon and Thurrock Hospitals NHS FoundationTrust
- Responsible party
- Sponsor
- Investigators
- Darrel Francis, MRCP, Study chair, Imperial College LondonChristopher A Rajkumar, Study director, Imperial College LondonRasha Al-Lamee, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742050
- Sponsor's protocol ID
- 18SM4531
- Acronym
- ORBITA-2
- Status last verified
- Sep 2023
- First submitted
- 13 Nov 2018
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41603507Foley 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.
PubMed 39462291Rajkumar 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.
PubMed 38015442Nowbar 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.
PubMed 35156616
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
- ClinicalTrials.gov ID
- NCT03742050
- Acronym / sponsor ID
- ORBITA-2 / 18SM4531
- Conditions
- Stable Angina
- Keywords
- Stable Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Basildon and Thurrock Hospitals NHS FoundationTrust
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Procedure: Percutaneous coronary interventionPercutaneous coronary intervention with drug-eluting stents and modern techniques |
| Placebo percutaneous coronary intervention | Placebo comparator | Procedure: Percutaneous coronary interventionPlacebo percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- Age younger than 18
- Age older than 85
- Recent acute coronary event
- Previous coronary artery bypass graft surgery
- Significant left main stem coronary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionAlso: Coronary angioplastyPercutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation | Procedure or surgery | Percutaneous coronary intervention, Placebo percutaneous coronary intervention |
Primary outcome
Change in angina symptom score between groups
Time frame: 12 weeks
7 secondary outcomes
Change in treadmill exercise time
Time frame: 12 weeks
Angina severity as assessed by Canadian Cardiovascular Society class
Time frame: 12 weeks
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
Time frame: 12 weeks
Quality of life as assessed with the EQ-5D-5L questionnaire
Time frame: 12 weeks
Change in dobutamine stress echocardiography score
Time frame: 12 weeks
Need for anti-anginal medication introduction and up-titration
Time frame: 12 weeks
Admission for acute coronary syndrome or unscheduled coronary angiography
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 41603507Simader 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.
- Derived from this study: PubMed 39462291Foley 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.
- Derived from this study: PubMed 38015442Rajkumar 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.
- Derived from this study: PubMed 35156616Nowbar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrel Francis, MRCP study chair
Imperial College London
Christopher A Rajkumar study director
Imperial College London
Rasha Al-Lamee principal investigator
Imperial College London
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Stable Angina, run by Imperial College London at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in angina symptom score between groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03742050, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.