Trial Documentation

These documents are for use by collaborators involved in the STOP-ACEi trial. They are the property of the University of Birmingham and Hull and East Yorkshire Hospitals NHS Trust and do not constitute any form of advice to participants.

Please see links below to download STOP-ACEi documentation.

STOP-ACEi Protocol and REC-approved study documents

STOP-ACEi Protocol

STOP-ACEi Protocol, V4.0, 25th April 2019 has now been released. Please contact the trial office to request a copy.

MRC START in STOP-ACEi Protocol, V1.0, 10th December 2014

STOP-ACEi PIS, GP Letters & Consent Form

STOP-ACEi Participant Information Sheet, V3.0 Standard, 10th December 2014

STOP-ACEi GDPR Addendum to the Participant Information Sheet, v1.0, 3rd December 2018

STOP-ACEi Participant Consent Form, V3.1, 24th March 2015

STOP-ACEi GP Letter - Treatment Continuation, V2.0, 6th January 2014

STOP-ACEi GP Letter - Treatment Discontinuation, V2.0, 6th January 2014

STOP-ACEi Text for participant thank you card or letter, v1.0, 25th April 2019 has now been released. Please contact the trial office to request a copy.

STOP-ACEi Other REC-approved documentation

STOP-ACEi Letter to accompany PIS, V2.0 Standard, 10th December 2014

STOP-ACEi Participant Advice Letter - Treatment Continuation, V1.0, 1st November 2013

STOP-ACEi Participant Advice Letter - Treatment Discontinuation, V1.0, 1st November 2013

STOP-ACEi Participant Diary, V1.0, 1st November 2013

STOP-ACEi Clinic Poster, V2.0, 6th January 2014

STOP-ACEi Advertising Text, V1.0, 1st November 2013

Version history

STOP-ACEi Amendment Log and Current Documents, V6.0, 22nd June 2020

STOP-ACEi CRFs and KDQOL-SF™ questionnaire

Please click the links below to download and print STOP-ACEi CRFs.

STOP-ACEi CRFs and Forms

STOP-ACEi CRF01: Randomisation Notepad, v1.2

STOP-ACEi CRF02: Baseline Visit, v1.1

STOP-ACEi CRF03: Telephone Follow-up, v1.0

STOP-ACEi CRF04: 3-Monthly Visit, v1.1

STOP-ACEi CRF05: Additional Hospital Admissions, v1.0

STOP-ACEi CRF06: Lab results, v1.0 (for central lab use only)

STOP-ACEi CRF10: SAE Form, v2.0

STOP-ACEi guide for clinical coding of SAEs, v1.0

KDQOL-SF™ questionnaire

The KDQOL-SF™ is reproduced here with permission from the RAND Corporation. Copyright © the RAND Corporation. RAND's permission to reproduce the survey is not an endorsement of the products, services, or other uses in which the survey appears or is applied.