Condition category
Urological and Genital Diseases
Date applied
02/05/2001
Date assigned
02/05/2001
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.astral.bham.ac.uk/

Contact information

Type

Scientific

Primary contact

Dr K Wheatley

ORCID ID

Contact details

University of Birmingham Clinical Trials Unit
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0000995

Study information

Scientific title

Acronym

ASTRAL

Study hypothesis

The ASTRAL trial is designed to address the issue of whether renal arterial revascularisation with balloon angioplasty and/or endovascular stenting can safely prevent progressive renal failure among a wide range of patients with atherosclerotic renovascular disease.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nephrology

Intervention

Patients in both arms will receive active intervention:
1. In the revascularisation arm, balloon angioplasty and/or endovascular stenting with medical management
2. In the medical therapy arm, drugs will be prescribed as considered appropriate

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is decline in renal function, as assessed by the slope of the reciprocal creatinine plot against time. Although single measures of serum creatine are a poor indicator of renal function in individual patients, serial measurements over up to 5 years will be made so patterns of change will be detectable. Furthermore, the assessment of differences in renal function between the two treatment arms with reciprocal creatine plots is statistically appropriate since the important factor is the average change in renal function with or without revascularisation.

Secondary outcome measures

Secondary end points are: blood pressure, urinary protein excretion; serious vascular events (such as myocardial infarction or stroke) and other event rates (including death and the need for dialysis); safety; and a single measure of angiographic patency at one year (in a subset of patients).

Overall trial start date

01/09/2000

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Atherosclerotic renovascular disease (ARVD) confirmed angiographically
2. At least one ARVD lesion that is suitable for revascularisation
3. No definite indication for, or contraindication to, revascularisation, and revascularisation unlikely to become definitely indicated within 6 months of entry
4. Informed consent obtained from patient

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

750

Participant exclusion criteria

1. Non-atherosclerotic renal arterial lesion (i.e. fibromuscular dysplasia).
2. Previous revascularisation procedure for ARVD.
3. Clear contraindication to revascularisation.

Eligibility will be based on the "uncertainty principle". That is, if there is a clear indication for, or contraindication to, revascularisation, that patient is not eligible for entry into ASTRAL. If, on the other hand, the patient's medical team is uncertain whether or not to revascularise, then that patient is eligible for randomisation. This approach allows an appropriately heterogeneous population of patients to be entered (since different clinicians will have varying areas of uncertainty), thereby leading to results which are more generalisable to the 'real world' and permitting investigation of treatment effects in different types of patient.

Recruitment start date

01/09/2000

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham Clinical Trials Unit
Birmingham
B15 2RR
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2007 interim results in http://www.ncbi.nlm.nih.gov/pubmed/17377602
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19907042

Publication citations

  1. Results

    , Wheatley K, Ives N, Gray R, Kalra PA, Moss JG, Baigent C, Carr S, Chalmers N, Eadington D, Hamilton G, Lipkin G, Nicholson A, Scoble J, Revascularization versus medical therapy for renal-artery stenosis., N. Engl. J. Med., 2009, 361, 20, 1953-1962, doi: 10.1056/NEJMoa0905368.

  2. Mistry S, Ives N, Harding J, Fitzpatrick-Ellis K, Lipkin G, Kalra PA, Moss J, Wheatley K, Angioplasty and STent for Renal Artery Lesions (ASTRAL trial): rationale, methods and results so far., J Hum Hypertens, 2007, 21, 7, 511-515, doi: 10.1038/sj.jhh.1002185.

Additional files

Editorial Notes