Condition category
Circulatory System
Date applied
24/02/2010
Date assigned
17/03/2010
Last edited
13/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adam de Belder

ORCID ID

Contact details

The Sussex Cardiac Centre
Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955 x 4897
adam.debelder@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 2.0

Study information

Scientific title

A multicentre randomised controlled trial of drug-eluting versus bare metal stents in the treatment of patients over 80 years of age with complex coronary artery disease

Acronym

XIMA

Study hypothesis

The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent (DES) technology will prove superior to bare metal stent (BMS) technology, with respect to a combined endpoint of mortality, myocardial infarction (MI), requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.

Ethics approval

King's college hospital research ethics committee approved on the 27th August 2008 ((ref: 08/H0808/107)

Study design

Multicentre randomised prospective controlled trial

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 contact details to request a patient information sheet

Condition

Coronary disease; acute coronary syndromes

Intervention

The treatment is a procedure percutaneous coronary intervention. Patients are randomised to receive either a Drug eluting stent or a Bare metal stent. Both arms are followed up for 1 year.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Combined primary outcome at 1 year
1.1. Death
1.2. Myocardial infarction
1.3. Target Vessel Failure
1.4. Major haemorrhage
2. Procedural cost

Secondary outcome measures

1. Angina status
2. Antianginal tablet prescription (Rx)
3. Procedural
3.1. Procedure success
3.2. Procedure Major Adverse Cardiac Events (MACE)
3.3. In-hospital complications
All secondary outcomes will be measured at 3, 6, 12 months.

Overall trial start date

01/10/2008

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 80 years
2. Stable angina or acute coronary syndrome
3. Coronary narrowing suitable for stenting that is either =15mm long and/or =3mm diameter.
4. Any lesion with high risk of restenosis eg chronic total occlusion (CTO), bifurcation, severe calcification
5. Any left main stem lesion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Acute ST-Segment Elevation Myocardial Infarction (STEMI)
2. Cardiogenic shock
3. Platelet count =50 x 109/mm^3
4. Patient life expectancy < 1 year
5. Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
6. Recent major gastrointestinal (GI) haemorrhage (within 3 months)
7. Any previous cerebral bleeding episode
8. Participation in another investigational drug or device study
9. Patient unable to give consent
10. Clinical decision precluding the use of DES

Recruitment start date

01/10/2008

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Spain, United Kingdom

Trial participating centre

The Sussex Cardiac Centre
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust (UK)

Sponsor details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955
scot.harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.bsuh.nhs.uk/home/

Funders

Funder type

Industry

Funder name

Abbott Laboratories Limited (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24216285

Publication citations

  1. Results

    de Belder A, de la Torre Hernandez JM, Lopez-Palop R, O'Kane P, Hernandez Hernandez F, Strange J, Gimeno F, Cotton J, Diaz Fernandez JF, Carrillo Saez P, Thomas M, Pinar E, Curzen N, Baz JA, Cooter N, Lozano I, Skipper N, Robinson D, Hildick-Smith D, , A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly)., J. Am. Coll. Cardiol., 2014, 63, 14, 1371-1375, doi: 10.1016/j.jacc.2013.10.053.

Additional files

Editorial Notes