Trial documents

Approved protocol

• PROTOCOL Clean 20250725 v 1.1 FINAL.pdf

Trial documents

• 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
• GP letter 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
• Poster for Patients clean 20260311 v1.4.docx   (updated 13 days ago)
• Poster for Ward Staff 20250131 V0.1.pdf
• Synopsis EOI CVD-Cog 20250623 v1.0 FINAL.pdf
• Telephone Discussion Record 20250623 v1.0 FINAL.pdf
• Trial Office Contacts 20260304 v1.0.docx   (updated 20 days ago)

Site training

• FAQs 20260320.pdf   (updated 4 days ago)
• SIV 20260309 V0.28.pdf   (updated 4 days ago)

Pharmacy documents

• IMP Accountability Log CLEAN 20260204 v1.1.docx
• Pharmacy Manual 20250321 V1.0.pdf
• Pharmacy Manual 20250321 v1.0.docx
• Study drug information sheet ISMN XL Cilostazol 20250623 v1.0 FINAL.pdf
• Study drug info sheet Cilostazol 20250623 v1.0 FINAL.pdf
• Study drug info sheet ISMN XL 20250623 v1.0 FINAL.pdf
• Study information sheet ISMN non-XL 20mg Cilostazol 20250623 v1.0 FINAL.pdf

Sponsor documents

• EOC Clinical Trials 20250801 - 20260731.pdf
• RF1 TA008 Attendance Investigator Training v1.0.pdf
• RF1 TA011 Participant Screening Enrolment Log v1.0.pdf
• RF2 TA008 Delegation Log for LIP v1.0.pdf
• SOP TA010 TMF TSF v2.0.pdf
• SOP TA011 ParticipantRecruitConsent V1.5.pdf
• SOP TA014 SAE Reporting V4.0.pdf
• SOP TA015 Trial closure V4.0.pdf

REC documents

• 1011543 Letter of HRA Approval 20250819.pdf
• PB CV 20230104 v1.0.pdf
• PB GCP NIHR 20240320.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

Minor amendments

Newsletters

• Newsflash20250625.pdf
• Newsflash20251008.pdf
• Newsletter 202602.pdf   (updated 2 days ago)

• 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