Lacunar Intervention Trial 1 (LACI-1)

NCT02481323 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-01-19

No results posted yet for this study

Summary

Phase II pilot randomised, factorial, short term dose escalation, open label, blinded intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety of cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease manifest as symptomatic small subcortical stroke.

Conditions

Interventions

DRUG

isosorbide mononitrate

slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis

DRUG

cilostazol

phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER
  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Joanna M Wardlaw, MD · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-08-31
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481323 on ClinicalTrials.gov