Condition category
Circulatory System
Date applied
13/03/2014
Date assigned
13/03/2014
Last edited
12/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 April 2018

Who is funding the study?
Medtronic International Trading Sàrl

Who is the main contact?
Mr Duncan Fatz
duncan.fatz@bsuh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Duncan Fatz

ORCID ID

Contact details

Brighton and Sussex University Hospitals NHS Trust
HIV Research Office
Sussex House
Abbey Road
Brighton
BN2 1ES
United Kingdom
-
duncan.fatz@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16226

Study information

Scientific title

Revascularisation or medical therapy in elderly patients with acute anginal syndromes

Acronym

RINCAL

Study hypothesis

Our 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).

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16226

Ethics approval

13/LO/1082

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis

Intervention

Percutaneous coronary intervention (PCI) or Coronary Artery Bypass Graft (CABG)

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Composite at 1 year of:
1. Death
2. Non-fatal myocardial infarction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2014

Overall trial end date

01/04/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 750; UK Sample Size: 750

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

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
Brighton
BN2 1ES
United Kingdom

Sponsor information

Organisation

Brighton & Sussex University Hospitals NHS Trust (UK)

Sponsor details

CIRU
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Medtronic International Trading Sàrl; Grant Codes: UK- SHQ –SBU

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/02/2016: Plain English summary added.