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

Imperial College London

Status: Completed

Conditions: Stable Angina

Treatments: Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03742050

18SM4531

Details and patient eligibility

About

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.

Enrollment: 439 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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439 participants in 2 patient groups, including a placebo group

Percutaneous coronary intervention

Active Comparator group

Description:

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Treatment:

Procedure: Percutaneous coronary intervention

Placebo percutaneous coronary intervention

Placebo Comparator group

Description:

Placebo percutaneous coronary intervention

Treatment:

Procedure: Percutaneous coronary intervention