A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina (ORBITA-2)

September 27, 2023 updated by: Imperial College London
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Basildon, United Kingdom
        • Basildon and Thurrock Hospitals NHS Foundation Trust
      • Bournemouth, United Kingdom, BH77DW
        • Royal Bournemouth Hospital
      • High Wycombe, United Kingdom, HP11 2TT
        • Wycombe Hospital
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom
        • Royal Free Hospital
      • Portsmouth, United Kingdom
        • Queen Alexandra Hospital
      • Reading, United Kingdom
        • Royal Berkshire NHS foundation trust
      • Uxbridge, United Kingdom, UB9 6JH
        • Harefield Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

ORBITA-2 will enrol patients who meet all 3 of the following 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:

  1. Age younger than 18
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other Names:
  • Coronary angioplasty
Placebo Comparator: Placebo percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other Names:
  • Coronary angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in angina symptom score between groups
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in treadmill exercise time
Time Frame: 12 weeks
12 weeks
Angina severity as assessed by Canadian Cardiovascular Society class
Time Frame: 12 weeks
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
12 weeks
Quality of life as assessed with the EQ-5D-5L questionnaire
Time Frame: 12 weeks
12 weeks
Change in dobutamine stress echocardiography score
Time Frame: 12 weeks
12 weeks
Need for anti-anginal medication introduction and up-titration
Time Frame: 12 weeks
12 weeks
Admission for acute coronary syndrome or unscheduled coronary angiography
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Basildon and Thurrock Hospitals NHS FoundationTrust

Investigators

  • Study Chair: Darrel Francis, MRCP, Imperial College London
  • Study Director: Christopher A Rajkumar, Imperial College London
  • Principal Investigator: Rasha Al-Lamee, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2018

Primary Completion (Actual)

September 6, 2023

Study Completion (Actual)

September 6, 2023

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18SM4531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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