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

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ClinicalTrials.gov Identifier: NCT03742050
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Basildon and Thurrock Hospitals NHS FoundationTrust
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Stable Angina Procedure: Percutaneous coronary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina Angioplasty

Arm Intervention/treatment
Active Comparator: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other Name: Coronary angioplasty

Placebo Comparator: Placebo percutaneous coronary intervention
Placebo percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other Name: Coronary angioplasty




Primary Outcome Measures :
  1. Change in angina symptom score between groups [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]
  8. Freedom from angina on symptom score [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742050


Contacts
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Contact: Rasha Al-Lamee, MRCP 020 7594 5735 rasha.al-lamee@nhs.net
Contact: Alexandra Nowbar, MRCP 020 7594 5735 alexandra.nowbar@nhs.net

Locations
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United Kingdom
Basildon and Thurrock Hospitals NHS Foundation Trust Recruiting
Basildon, United Kingdom
Contact: Thomas Keeble, MD       thomas.keeble@btuh.nhs.uk   
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Rasha K Al-Lamee, MRCP    07517551868    rasha.al-lamee@nhs.net   
Contact: Alexandra N Nowbar, MRCP    02075945735    alexandra.nowbar@nhs.net   
Principal Investigator: Rasha K Al-Lamee, MRCP         
Royal Berkshire NHS Foundation Trust Recruiting
Reading, United Kingdom
Contact: Neil Ruparelia, MRCP       neil.ruparelia@nhs.net   
Sponsors and Collaborators
Imperial College London
Basildon and Thurrock Hospitals NHS FoundationTrust
Investigators
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Study Chair: Darrel Francis, MRCP Imperial College London
Study Director: Alexandra Nowbar Imperial College London
Principal Investigator: Rasha Al-Lamee Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03742050     History of Changes
Other Study ID Numbers: 18SM4531
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms