Trial documents

Approved protocol

• PROTOCOL Clean 20250725 v 1.1 FINAL.pdf

Expression of interest

• Synopsis and EOI 20250401 v2.0.docx

Trial documents

• GP letter Clean 20250725 v1.1 FINAL.docx
• Poster for Patients clean 20260311 v1.4.docx
• Poster for Ward Staff 20250131 V0.1.pdf
• Randomisation CRF Print-out for Tasks 20260608 v1.1.docx   (updated 2 days ago)
• Synopsis EOI CVD-Cog 20250623 v1.0 FINAL.pdf
• Telephone Discussion Record 20250623 v1.0 FINAL.pdf
• Trial Office Contacts 20260330 v1.1.docx
• Version Control Table 20260609.docx   (updated 1 day ago)

Site training

• FAQs 20260330.pdf
• Pharmacy SIV 20260331 v1.2.pdf
• SIV 20260416 v2.1 pdf.pdf

Information sheets and consent forms

• Combined Participant Information and Consent Form Clean 20251107 v1.2 FINAL.docx
• Consent to Contact Form (CTC) Clean 20250725 v1.1 FINAL.docx
• Contraception Information Sheet Clean 20250725 v1.1 FINAL.docx
• Informant Consent to Contact Form 20250623 v1.0 FINAL.docx
• Informant Information Sheet (PIS) Clean 20250725 v1.1 FINAL.docx
• Legal Rep Information Sheet (LR-PIS) Clean 20251107 v1.2 FINAL.docx
• Legal Rep Informed Consent Form (ICF) Clean 20250725 v1.1 FINAL.docx
• Participant Information Sheet (PIS) Clean 20251107 v1.2 FINAL.docx
• Participant Informed Consent Form (ICF) 20250623 v1.0 FINAL.docx
• Study drug information sheet Cilostazol v2.0 20260326 CLEAN.docx   (updated 9 days ago)
• Study drug information sheet ISMN XL Cilostazol v2.0 20260326 CLEAN.docx   (updated 9 days ago)
• Study drug information sheet ISMN XL v2.0 20260326 CLEAN (2).docx   (updated 9 days ago)
• Study drug information sheet ISMN non-XL 20mg Cilostazol v2.0 20260326 CLEAN (2).docx   (updated 9 days ago)
• Study drug information sheet ISMN non XL 20 mg v2.0 20260326 CLEAN (2).docx   (updated 9 days ago)

Pharmacy documents

• IMP Accountability Log CLEAN 20260204 v1.1.docx
• IMP drug label Final 20260605 v2.1.docx   (updated 1 day ago)
• Pharmacy Manual 20250321 V1.0.pdf

Sponsor documents

• Evidence of Cover Clinical Trials 20250801 - 20260731.pdf
• File Note 025 - Role Y on paper delegation log 20260605.pdf   (updated 5 days ago)
• RF1 CT19 CTIMP SAE Report Form v1.0 26 Mar 2026.pdf
• RF2 CT12 ISF Contents v1.0 25 Mar 2026.pdf
• RF3 CT12 File Note v1.0 25 Mar 2026.docx   (updated 29 days ago)
• RF4 CT15 May 2026 Trial Location Delegation Log v1.0 25 Mar 2026.docx   (updated 5 days ago)
• RF6 CT15 Trial Location Training Log v1.0 25 Mar 2025.docx
• RF8 CT15 Screening and Enrolment Log v1.0 25 Mar 2025.pdf
• RF9 CT15 Participant Identification Log v1.0 25 Mar 2026.pdf
• SOP CT19 CTIMP Safety Reporting v1.0 26 Mar 2026 - signed.pdf
• SOP CT22 Urgent Safety Measures v1.0 26 Mar 2026 - signed.pdf
• SOP TA011 ParticipantRecruitConsent V1.5.pdf
• SOP TA015 Trial closure V4.0.pdf

REC documents

• 1011543 Letter of HRA Approval 20250819.pdf
• CV Philip Bath 20260217.pdf
• GCP E6(R3) Philip Bath Certificate of completion 20260419.pdf
• REC Approval 1011543 25WM0144 Favourable opinion on further information 20250825.pdf

MHRA documents

• CTA Acceptance of Amended Request 20250815.pdf
• Cilostazol 100 mg tablets SmPC Mylar 20200309.pdf
• Isodur 50XL Capsules SmPC 20240409.pdf
• Isosorbide Mononitrate Tablets 20 mg SmPC 20180101.pdf

Substantial amendments

Minor amendments

• MA/05/26 /
• MA/04/26 /
• MA/03/26 /
• MA/02/26 /
• MA/01/26 /

Trial working practice documents

• WPD 001 Screening and Enrolment Log 20260114 v1.0.pdf   (updated 29 days ago)
• WPD 002 Consent 20260114 v1.0.pdf   (updated 29 days ago)
• WPD 003 Manual Randomisation 20260114 v1.0.pdf   (updated 29 days ago)
• WPD 005 Manual CRFs and SAEs 20260304 v1.0.pdf   (updated 29 days ago)
• WPD 006 Central Follow-Ups 20260408 v1.0.pdf   (updated 28 days ago)
• WPD 007 Protocol Deviations and Violations 20260303 v1.0.pdf   (updated 29 days ago)
• WPD 008 Entering missing data data queries and corrections 20260312 v1.0.pdf   (updated 29 days ago)
• WPD 009 Document Prep and Upload 20260114 v1.0.pdf   (updated 28 days ago)
• WPD 010 Secure Vault Uploads 20260114 v1.0.pdf   (updated 28 days ago)
• WPD 011 Baseline Cognitive Assessments 20260417 v1.0.pdf   (updated 28 days ago)
• WPD 012 Randomisation on Database 20260417v1.0.pdf   (updated 28 days ago)
• WPD 013 Serious Adverse Event Reporting 20260303 v1.0.pdf   (updated 28 days ago)

Newsletters

• Newsflash20250625.pdf
• Newsflash20251008.pdf
• Newsletter 202602.pdf
• Newsletter 202603.pdf
• Newsletter 202604.pdf

• Randomisation v1.0
• Baseline v1.0
• IQCODE baseline v1.0
• Week 1-2 follow-up v1.0
• Week 3-4 follow-up v1.0
• Discharge or death in hospital v1.0
• Prescription issue v1.0
• No set visit v1.0
• Outcome v1.0
• Serious Adverse Event v1.0   (see also list of sub-categories)
• Data correction request v1.0