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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stable Angina

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous coronary intervention<br>Percutaneous coronary intervention with drug-eluting stents and modern techniques | Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation<br>* Other names: Coronary angioplasty;|
| Placebo Comparator: Placebo percutaneous coronary intervention<br>Placebo percutaneous coronary intervention | Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation<br>* Other names: Coronary angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in angina symptom score between groups |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable Angina