Clinical trial NCT03742050: A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Official title: A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Keywords: Stable Angina
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Basildon and Thurrock Hospitals NHS FoundationTrust
First posted: 2018-11-15
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in angina symptom score between groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in treadmill exercise time
timeFrame: 12 weeks
measure: Angina severity as assessed by Canadian Cardiovascular Society class
timeFrame: 12 weeks
measure: Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
timeFrame: 12 weeks
measure: Quality of life as assessed with the EQ-5D-5L questionnaire
timeFrame: 12 weeks
measure: Change in dobutamine stress echocardiography score
timeFrame: 12 weeks
measure: Need for anti-anginal medication introduction and up-titration
timeFrame: 12 weeks
measure: Admission for acute coronary syndrome or unscheduled coronary angiography
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock Hospitals NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: High Wycombe
country: United Kingdom
facility: Wycombe Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: Uxbridge
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: Imperial College London
name: Darrel Francis, MRCP
role: STUDY_CHAIR
affiliation: Imperial College London
name: Christopher A Rajkumar
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Rasha Al-Lamee
role: PRINCIPAL_INVESTIGATOR
References:
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.