Revascularisation or medical therapy in elderly patients with acute anginal syndromes
| ISRCTN | ISRCTN10487159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10487159 |
| ClinicalTrials.gov number | NCT02086019 |
| Secondary identifying numbers | 16226 |
- Submission date
- 13/03/2014
- Registration date
- 13/03/2014
- Last edited
- 13/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Acute coronary syndrome (ACS) is a term referring to various heart conditions, including heart attacks. Despite the enormous amount of research around ACS, there is only a very small amount of data on the management of ACS in the elderly, octogenarian population. About 33% of all ACS episodes in the UK occur in patients aged over 75. The incidence of ACS in the octogenarian is projected to increase due to advances in ACS treatment in an aging population. A non-ST segment elevation myocardial infarction (NSTEMI) is a less serious heart attack where the supply of blood to the heart is only partially blocked. Treatment for NSTEMI can be divided into two groups: optimal medical therapy (OMT) or OMT plus revascularisation. OMT consists of the medications heparin, aspirin, clopidogrel, beta blocker and a statin followed by a plan to optimise long-term medical treatment in order to reduce future cardiac events. OMT plus revascularisation refers to OMT together with a coronary angiogram (X-ray of the heart) followed by either stent insertion or coronary artery bypass graft surgery (CABG). As yet, no large studies comparing OMT with OMT plus revascularisation have been undertaken in octogenarian patients. The small amount of data that is available appears to demonstrate a greater benefit from revascularisation, yet it is common for this to be denied to them. Our aim is to recruit over 700 patients aged 80 or over to a study comparing OMT with OMT plus revascularisation.
Who can participate?
NSTEMI patients aged 80 or over
What does the study involve?
Participants are randomly allocated to be treated with either OMT or OMT plus revascularisation.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Brighton and Sussex University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2014 to September 2019
Who is funding the study?
Medtronic International Trading Sàrl
Who is the main contact?
Mr Duncan Fatz
duncan.fatz@bsuh.nhs.uk
Contact information
Scientific
Brighton and Sussex University Hospitals NHS Trust
HIV Research Office
Sussex House
Abbey Road
Brighton
BN2 1ES
United Kingdom
| duncan.fatz@bsuh.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Revascularisation or medical therapy in elderly patients with acute anginal syndromes |
| Study acronym | RINCAL |
| Study hypothesis | The aim is to recruit over 700 patients 80 years or over to a randomised controlled trial comparing revascularisation plus OMT (invasive arm) versus optimal medical therapy (conservative arm). |
| Ethics approval(s) | London - Brighton & Sussex Research Ethics Committee, 27/11/2013, ref: 13/LO/1082 |
| Condition | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis |
| Intervention | Percutaneous coronary intervention (PCI) or Coronary Artery Bypass Graft (CABG) |
| Intervention type | Mixed |
| Primary outcome measure | Composite at 1 year of: 1. Death 2. Non-fatal myocardial infarction |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2014 |
| Overall study end date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 750; UK Sample Size: 750 |
| Total final enrolment | 251 |
| Participant inclusion criteria | 1. Age 80 or over 2. Non STEMI characteristic chest pain accompanied by typical ischaemic ECG changes a troponin rise 3. Suitable for conservative or invasive strategy |
| Participant exclusion criteria | 1. Acute STEMI 2. Cardiogenic shock 3. Lack of suitability for whatever clinical reason to be randomised (any condition in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in the study) 4. Platelet count =50 x 109/mm3 5. Patient life expectancy < 1 year 6. Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent 7. Drug elutant 8. Recent major GI haemorrhage (within 3 months) 9. Any previous cerebral bleeding episode 10. Participation in another investigational drug or device study 11. Patient unable to give consent 12. Clinical decision precluding the use of stents |
| Recruitment start date | 01/04/2014 |
| Recruitment end date | 01/09/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BN2 1ES
United Kingdom
Sponsor information
Hospital/treatment centre
CIRU, Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Adam de Belder (a.debelder@nhs.net). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/05/2021 | 11/10/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/10/2021: IPD sharing statement added.
11/10/2021: Publication reference and total final enrolment added.
05/08/2019: ClinicalTrials.gov number added.
16/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2018 to 01/09/2018.
2. The overall trial end date was changed from 01/04/2018 to 01/09/2019.
12/02/2016: Plain English summary added.
