Skip to main content
OpenTrials
Completed

NCT Number: NCT03742050

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basildon and Thurrock Hospitals NHS Foundation Trust, Basildon, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Other names: Coronary angioplasty

Primary outcomes

  1. Change in angina symptom score between groups

    Time frame: 12 weeks

Secondary outcomes

  1. Change in treadmill exercise time

    Time frame: 12 weeks

  2. Angina severity as assessed by Canadian Cardiovascular Society class

    Time frame: 12 weeks

  3. Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire

    Time frame: 12 weeks

  4. Quality of life as assessed with the EQ-5D-5L questionnaire

    Time frame: 12 weeks

  5. Change in dobutamine stress echocardiography score

    Time frame: 12 weeks

  6. Need for anti-anginal medication introduction and up-titration

    Time frame: 12 weeks

  7. Admission for acute coronary syndrome or unscheduled coronary angiography

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Basildon and Thurrock Hospitals NHS FoundationTrust

Registry information

Acronym: ORBITA-2

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2018
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.