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

Primary Purpose

Stable Angina

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Stable Angina

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Basildon and Thurrock Hospitals NHS Foundation Trust
  • Royal Bournemouth Hospital
  • Wycombe Hospital
  • Imperial College Healthcare NHS Trust
  • Royal Free Hospital
  • Queen Alexandra Hospital
  • Royal Berkshire NHS Foundation Trust
  • Harefield Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Percutaneous coronary intervention

Placebo percutaneous coronary intervention

Arm Description

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Placebo percutaneous coronary intervention

Outcomes

Primary Outcome Measures

Change in angina symptom score between groups

Secondary Outcome Measures

Change in treadmill exercise time
Angina severity as assessed by Canadian Cardiovascular Society class
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
Quality of life as assessed with the EQ-5D-5L questionnaire
Change in dobutamine stress echocardiography score
Need for anti-anginal medication introduction and up-titration
Admission for acute coronary syndrome or unscheduled coronary angiography

Full Information

First Posted
November 13, 2018
Last Updated
September 27, 2023
Sponsor
Imperial College London
Collaborators
Basildon and Thurrock Hospitals NHS FoundationTrust
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1. Study Identification

Unique Protocol Identification Number
NCT03742050
Brief Title
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Acronym
ORBITA-2
Official Title
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
September 6, 2023 (Actual)
Study Completion Date
September 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Basildon and Thurrock Hospitals NHS FoundationTrust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina
Keywords
Stable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous coronary intervention
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Arm Title
Placebo percutaneous coronary intervention
Arm Type
Placebo Comparator
Arm Description
Placebo percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
Coronary angioplasty
Intervention Description
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Primary Outcome Measure Information:
Title
Change in angina symptom score between groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in treadmill exercise time
Time Frame
12 weeks
Title
Angina severity as assessed by Canadian Cardiovascular Society class
Time Frame
12 weeks
Title
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
Time Frame
12 weeks
Title
Quality of life as assessed with the EQ-5D-5L questionnaire
Time Frame
12 weeks
Title
Change in dobutamine stress echocardiography score
Time Frame
12 weeks
Title
Need for anti-anginal medication introduction and up-titration
Time Frame
12 weeks
Title
Admission for acute coronary syndrome or unscheduled coronary angiography
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel Francis, MRCP
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christopher A Rajkumar
Organizational Affiliation
Imperial College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha Al-Lamee
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basildon and Thurrock Hospitals NHS Foundation Trust
City
Basildon
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH77DW
Country
United Kingdom
Facility Name
Wycombe Hospital
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
Country
United Kingdom
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom
Facility Name
Harefield Hospital
City
Uxbridge
ZIP/Postal Code
UB9 6JH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35156616
Citation
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.
Results Reference
derived

Learn more about this trial

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

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