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| Name | Class |
|---|---|
| Basildon and Thurrock Hospitals NHS FoundationTrust | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous coronary intervention | Active Comparator | Percutaneous coronary intervention with drug-eluting stents and modern techniques |
|
| Placebo percutaneous coronary intervention | Placebo Comparator | Placebo percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in angina symptom score between groups | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrel Francis, MRCP | Imperial College London | Study Chair |
| Christopher A Rajkumar | Imperial College London | Study Director |
| Rasha Al-Lamee | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basildon and Thurrock Hospitals NHS Foundation Trust | Basildon | United Kingdom | ||||
| Royal Bournemouth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41603507 | Derived | 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. | |
| 39462291 |
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|
| 12 weeks |
| Quality of life as assessed with the EQ-5D-5L questionnaire | 12 weeks |
| Change in dobutamine stress echocardiography score | 12 weeks |
| Need for anti-anginal medication introduction and up-titration | 12 weeks |
| Admission for acute coronary syndrome or unscheduled coronary angiography | 12 weeks |
| Bournemouth |
| BH77DW |
| United Kingdom |
| Wycombe Hospital | High Wycombe | HP11 2TT | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | 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 | UB9 6JH | United Kingdom |
| 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. |
| 38015442 | 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. |
| 35156616 | 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. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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