ORBITA: Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02062593
• Collaborator: Volcano Corporation (Industry)
• Enrollment: 230
• Locations: 5
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site: 46
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina	Procedure: Coronary angioplasty	N/A

Detailed Description

The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coronary angioplasty and optimum medical therapy Percutaneous coronary intervention and optimal medical therapy	Procedure: Coronary angioplasty; Percutaneous coronary intervention with drug-eluting stents and modern techniques; Other Names: Percutaneous coronary intervention
Placebo Comparator: Sham procedure and optimum medical therapy Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy	Procedure: Coronary angioplasty; Percutaneous coronary intervention with drug-eluting stents and modern techniques; Other Names: Percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

1. Exercise Time on Treadmill [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation

Exclusion Criteria:

• Acute coronary syndrome

• Previous coronary artery bypass graft surgery

• Left main stem disease

• Contraindications to PCI or drug-eluting stent (DES) implantation

• Heavily calcified or tortuous vessels

• Chronic total occlusion in target vessel

• Life expectancy <2yr

• Pregnancy

• Age <18yr or >85yr

• Angiographic stenosis ≥ 50% in non-target vessel

• Inability to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Sussex Healthcare NHS Trust	Saint Leonards-on-sea	East Sussex	United Kingdom	TN37 7RD
2	Basildon and Thurrock University Hospitals NHS Trust	Basildon		United Kingdom	SS16 5NL
3	The Royal Bournemouth and Christchurch Hospitals NHS Trust	Bournemouth		United Kingdom	BH7 7DW
4	Royal Devon & Exeter Foundation Trust	Exeter		United Kingdom	EX2 5DW
5	Imperial College Healthcare NHS Trust	London		United Kingdom

Sponsors and Collaborators

• Imperial College London
• Volcano Corporation

Investigators

• Principal Investigator: Justin E Davies, MRCP, PhD, Imperial College London
• Study Chair: Darrel P Francis, MRCP, MD, Imperial College London
• Study Director: Rasha K Al-Lamee, MRCP, Imperial College London

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 14, 2014

More Information

Additional Information:

• Online Protocol Summary

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT02062593
• Other Study ID Numbers: ORBITA-1
• First Posted: Feb 13, 2014
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Imperial College London: Stable angina; Percutaneous coronary intervention; Optimal medical therapy; Sham-control
• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable

Study Results

Participant Flow

Arm/Group Title	Coronary Angioplasty and Optimum Medical Therapy	Sham Procedure and Optimum Medical Therapy
Arm/Group Description	Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
Period Title: Overall Study
STARTED	105	95
COMPLETED	105	91
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	Coronary Angioplasty and Optimum Medical Therapy	Sham Procedure and Optimum Medical Therapy	Total
Arm/Group Description	Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Total of all reporting groups
Overall Participants	105	95	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (9.5)	66.1 (8.4)	66 (9)
Sex: Female, Male (Count of Participants)
Female	31 29.5%	23 24.2%	54 27%
Male	74 70.5%	72 75.8%	146 73%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	105 100%	95 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Exercise Time on Treadmill
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

No exercise time data available for 1 patient in PCI group and 5 patients in placebo group

Arm/Group Title	Coronary Angioplasty and Optimum Medical Therapy	Sham Procedure and Optimum Medical Therapy
Arm/Group Description	Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
Measure Participants	104	90
Mean (95% Confidence Interval) [seconds]	28.4	11.8

Adverse Events

Time Frame	Total study time 12 weeks
Arm/Group Title	Coronary Angioplasty and Optimum Medical Therapy		Sham Procedure and Optimum Medical Therapy
Arm/Group Description	Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques		Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
All Cause Mortality
	Coronary Angioplasty and Optimum Medical Therapy		Sham Procedure and Optimum Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/95 (0%)
Serious Adverse Events
	Coronary Angioplasty and Optimum Medical Therapy		Sham Procedure and Optimum Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/105 (3.8%)		14/95 (14.7%)
Blood and lymphatic system disorders
Major bleeding	2/105 (1.9%)	2	3/95 (3.2%)	3
Cardiac disorders
Crossover to PCI	0/105 (0%)	0	4/95 (4.2%)	4
Wire snapped required snare retrieval	1/105 (1%)	1	0/95 (0%)	0
Acute coronary syndrome	0/105 (0%)	0	1/95 (1.1%)	1
Hospitalisation for atypical chest pain	0/105 (0%)	0	1/95 (1.1%)	1
Hospitalisation for right heart failure	0/105 (0%)	0	1/95 (1.1%)	1
Immune system disorders
Severe drug reaction	0/105 (0%)	0	1/95 (1.1%)	1
Musculoskeletal and connective tissue disorders
Hospitalisation for leg pain	0/105 (0%)	0	1/95 (1.1%)	1
Nervous system disorders
Acute confusion	1/105 (1%)	1	0/95 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema	0/105 (0%)	0	2/95 (2.1%)	2
Other (Not Including Serious) Adverse Events
	Coronary Angioplasty and Optimum Medical Therapy		Sham Procedure and Optimum Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/95 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.