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

Not Applicable

Completed

• Conditions: Stable Angina
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT03742050
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-12
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Status Verified: 2023-09
• Primary Completion: 2023-09-06
• Study Completion: 2023-09-06
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo percutaneous coronary intervention	Percutaneous coronary intervention	Placebo percutaneous coronary intervention
Percutaneous coronary intervention	Percutaneous coronary intervention	Percutaneous coronary intervention with drug-eluting stents and modern techniques

Primary Outcome Measures

Name	Time	Method
Change in angina symptom score between groups	12 weeks

Secondary Outcome Measures

Name	Time	Method
Need for anti-anginal medication introduction and up-titration	12 weeks
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	12 weeks
Quality of life as assessed with the EQ-5D-5L questionnaire	12 weeks
Change in dobutamine stress echocardiography score	12 weeks
Admission for acute coronary syndrome or unscheduled coronary angiography	12 weeks

Trial Locations

Locations (8)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Basildon and Thurrock Hospitals NHS Foundation Trust; 🇬🇧 Basildon, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Wycombe Hospital; 🇬🇧 High Wycombe, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom

Harefield Hospital; 🇬🇧 Uxbridge, United Kingdom