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

Stable Angina Clinical Trial

— ORBITA-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742050
• Other study ID #: 18SM4531
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Intervention

Procedure:
• Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation

Locations

Country	Name	City	State
United Kingdom	Basildon and Thurrock Hospitals NHS Foundation Trust	Basildon
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Wycombe Hospital	High Wycombe
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading
United Kingdom	Harefield Hospital	Uxbridge

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Basildon and Thurrock Hospitals NHS FoundationTrust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in angina symptom score between groups		12 weeks
Secondary	Change in treadmill exercise time		12 weeks
Secondary	Angina severity as assessed by Canadian Cardiovascular Society class		12 weeks
Secondary	Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire		12 weeks
Secondary	Quality of life as assessed with the EQ-5D-5L questionnaire		12 weeks
Secondary	Change in dobutamine stress echocardiography score		12 weeks
Secondary	Need for anti-anginal medication introduction and up-titration		12 weeks
Secondary	Admission for acute coronary syndrome or unscheduled coronary angiography		12 weeks