Condition category
Circulatory System
Date applied
25/08/2009
Date assigned
07/10/2009
Last edited
27/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.wolfson.qmul.ac.uk/epm/research/prami/index.html

Contact information

Type

Scientific

Primary contact

Dr David Wald

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/H0703/109

Study information

Scientific title

Preventive Angioplasty in Myocardial Infarction Trial: a randomised controlled trial

Acronym

PRAMI

Study hypothesis

A randomised trial among patients with an acute myocardial infarction (AMI) undergoing a therapeutic angioplasty (a procedure to unblock the artery causing the AMI), to determine the value of preventive angioplasty (additional angioplasty to dilate all other narrowed coronary arteries that were not the cause of the AMI but may cause a future infarct) undertaken as an immediate follow-on procedure.

Ethics approval

East London and the City Research Ethics Committee approved in December 2007

Study design

Randomised 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 the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

Six hundred patients with AMI will be allocated at random to receive therapeutic angioplasty alone or therapeutic angioplasty plus preventive angioplasty undertaken as an immediate follow-on procedure. Patients will be followed up for an average of 3 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

All outcomes will be recorded during the period of follow up and analysed 1 year after the last patient is recruited:
1. Death
2. Non-fatal MI
3. Refractory angina

Secondary outcome measures

All outcomes will be recorded during the period of follow up and analysed 1 year after the last patient is recruited:
1. Repeat revascularisation
2. Complications of angioplasty
3. Angina score
4. EQ510
5. Economic evaluation

Overall trial start date

14/04/2008

Overall trial end date

14/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (no age limits, either sex) with acute myocardial infarction undergoing a therapeutic angioplasty to the infarct related artery

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Cardiogenic shock
2. Coronary artery bypass graft (CABG)

Recruitment start date

14/04/2008

Recruitment end date

14/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Clinical Operations Manager
Joint R & D Office
Barts and the London Trust/Barts and the London School of Medicine & Dentistry
QM Innovation Centre
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Charity

Funder name

Bart's and the London Trust (BLT) Charitable Foundation (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/23991625

Publication citations

  1. Results

    Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG, , Randomized trial of preventive angioplasty in myocardial infarction., N. Engl. J. Med., 2013, 369, 12, 1115-1123, doi: 10.1056/NEJMoa1305520.

Additional files

Editorial Notes