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NCT03742050: ORBITA-2

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

Completed NA Last updated 29 September 2023
What this trial tests

NA trial testing Percutaneous coronary intervention in Stable Angina in 439 participants. Completed in 6 September 2023.

Timeline
12 November 2018
Primary endpoint
6 September 2023
6 September 2023

Quick facts

Lead sponsorImperial College London
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment439
Start date12 November 2018
Primary completion6 September 2023
Estimated completion6 September 2023
Sites8 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Imperial College London

Who can join

Adults 18 to 85, any sex, with Stable Angina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.
    Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Nowbar AN, et al · · 2023 · cited 147× · PMID 38015442 · DOI 10.1056/nejmoa2310610
  2. Cardiopulmonary exercise testing and efficacy of percutaneous coronary intervention: a substudy of the ORBITA trial.
    Ganesananthan S, Rajkumar CA, Foley M, Thompson D, et al · · 2022 · cited 21× · PMID 35639660 · DOI 10.1093/eurheartj/ehac260
  3. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease.
    Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader F, et al · · 2025 · cited 17× · PMID 39462291 · DOI 10.1161/circulationaha.124.072281
  4. Remote digital smart device follow-up in prospective clinical trials: early insights from ORBITA-2, ORBITA-COSMIC, and ORBITA-STAR.
    Ganesananthan S, Rajkumar CA, Foley M, Francis D, et al · · 2022 · cited 16× · PMID 36382002 · DOI 10.1093/eurheartjsupp/suac058
  5. 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.
    Nowbar AN, Rajkumar C, Foley M, Ahmed-Jushuf F, et al · · 2022 · cited 15× · PMID 35156616 · DOI 10.4244/eij-d-21-00649
  6. Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review.
    Marquis-Gravel G, Moliterno DJ, Francis DP, Jüni P, et al · · 2020 · cited 8× · PMID 32703515 · DOI 10.1016/j.jacc.2020.05.060
  7. Optimising physiological endpoints of percutaneous coronary intervention.
    Al-Lamee R, Rajkumar CA, Ganesananthan S, Jeremias A. · · 2021 · cited 7× · PMID 33792544 · DOI 10.4244/eij-d-20-00988
  8. Association Between Age and PCI Effectiveness in Stable CAD: Secondary Analysis of ORBITA-2.
    Simader FA, Rajkumar CA, Foley MJ, Ahmed-Jushuf F, et al · · 2026 · cited 1× · PMID 41603507 · DOI 10.1016/j.jacc.2025.10.086

Verify or expand the search:

Other trials of Percutaneous coronary intervention

Trials testing the same drug.

Other recruiting trials for Stable Angina

Currently open trials in the same condition.

Other Imperial College London trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03742050.

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