LACI-3 trial – LACunar Intervention trial 3

Trial documents

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Approved protocol	Protocol v 4.0 26.11.2025.pdf

Trial documents	10. LACI-3 Month 6 follow-up 20251218 v1.0.pdf 11. LACI-3 Month 12 follow-up 20251218 v1.0.pdf 12. LACI-3 Month 18 follow-up 20251218 v1.0.pdf Baseline EQ5D5L EQ-VAS v 1.0 21 October 2024.pdf Baseline Trail Making Test (TMT) Part B v 1.0 21 October 2024.pdf Delgation Log v 1.0 26.02.2025.docx Dose Escalation and Symptom Management Guide v 2.0 02.10.2025 Final.pdf Eligibility Assessment Guide v 3.0 25.09.25.pdf Eligibility Checklist v.4.0 10.12.2025.pdf Eligibility Recording v 1.0 12.06.2025.pdf File Note v 1.0 17.04.2025.docx Medical staff Poster v 1.0 21.10.24.docx MoCA-8.3-English-Instructions-2020.pdf MoCA-8.3-English-Test-2020.pdf Recruitment Checklist v.4.0 21.09.2025.pdf Recruitment Script v 2.0 17.11.2025.pdf

Information sheets and consent forms	Contact Form v 2.0 27 January 2025.pdf Facts Sheet 20241021 V1.0.pdf Participant Consent Form 20241021 V1.0.pdf Participant Information Sheet 20250516 V 3.0.pdf

Pharmacy documents	Cilostazol 100 mg tablets - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf Clinical Trial Drug Prescription Form v 2.0 05 February 2025.doc Isodur 25XL Capsules - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf Isosorbide Mononitrate Tablets 20 mg - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf Study Specific IMP Label v 1.0 21 October 2024.pdf Participant IMP Accountability Log v 1.0 12.11.2024.pdf Pharmacy Manual v 1.0 12.02.2025.pdf Representative Summary of Product Characteristics v 1.0 21.10.24 encrypted.pdf Study PACK Cilostazol v 2.0 4 August 2025.docx Study PACK ISMN XL Cilostazol v 2.0 4 August 2025.docx Study PACK ISMN XL v 2.0 4 August 2025.docx Study PACK ISMN non-XL 20mg Cilostazol v 3.0 4 August 2025.docx Study PACK ISMN non XL 20 mg v 2.0 4 August 2025.docx

Sponsor documents	CR005-F02 Pregnancy Notification Form v8.0 (1).docx DNA LACUNAR 2.pdf GCP Deviation Log v5.0.docx GCP Violation Reporting Form v6.0 (1).docx OASIS.pdf

REC documents	24-SS-0095-Updated FO On Further Info Letter 22-01-2024.pdf

MHRA documents	CTA Acceptance of Amended Request.pdf

Substantial amendments	» SA/01/25 /

Minor amendments	MA/08/26 / MA/07/26 / MA/06/26 / MA/05/26 / MA/04/25 / MA/03/25 / MA/02/25 /

Trial working practice documents	E-CRF Data Entry Manual V2.0 17092025.pdf Follow-up Checklist v.1.0 19.01.26.pdf IMP Re-supply for sites v 2.0 15.12.2025.pdf Imaging Acquisition Guidelines LACI3 v.1.0 20250408.pdf Imaging Transfer Guidelines v.1.0 20250408.pdf Web upload guidelines v.1.0 LACI3 20250408.pdf

Videos	Webinar 1 - 23.09.2025.mp4 Webinar 3-01.12.2025.mp4 Webinar 4-20260119.mp4 Webinar 2-14.10.2025.mp4

Printable CRFs	(updated 96 days ago) Randomisation v1.2 Baseline v1.0 Week 1-2 follow-up v1.3 Week 3-4 follow-up v1.3 Month 6 follow-up v1.0 Month 12 follow-up v1.0 Month 18 follow-up 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 v1.1 Please log in to download a zip archive of printable CRFs. Participant contact details should be submitted directly online. A printable preview of the contact details form is available here.
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