Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler "ECLIPse"

Completed

Phase 4 Results

Trial Description

RATIONALE:
- Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been postulated to reflect downstream increased vascular resistance caused by small-vessel disease (SVD).
- Small arterial vessels are a significant determinant of vascular resistance and PIs are elevated when SVD is present in the intracranial circulation.
- Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such as vasodilation and neuroprotective effect. It has been shown to be effective in the secondary prevention of stroke especially in the SVD and it may be related to the other non-antiplatelet effects of cilostazol.
OBJECTIVES:
- In this study, we aim to investigate whether cilostazol affects the changes of PIs in patients with acute lacunar infarction using serial TCDs.
- Our hypothesis is that cilostazol has other non-antiplatelet effects such as vasodilation effect and may decrease the vascular resistance in patients with acute lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute lacunar infarction.

Detailed Description

TREATMENTS:
- Cilostazol is an agent inhibiting platelet aggregation.
- A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet.
TREATMENT PLAN:
- There will be two treatment groups; one will receive cilostazol 200mg (100mg twice per day), the second matching placebo of cilostazol.
- These study drugs will be administered on top of aspirin (100mg) systematically prescribed to such patients
PRIMARY ENDPOINT:
- The changes of PI between the baseline and 14 and 90 days follow-up study.
STUDY EXECUTION:
- Two hundred sixty patients, presenting with first ever lacunar infarction within 7 days after the onset of symptoms will be recruited within two years.
- Patients will be followed up during the three months.

Conditions

Interventions

  • Aspirin (acute stroke) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
    Intervention Desc: Aspirin (100mg) plus cilostazol (200mg)
    ARM 1: Kind: Experimental
    Label: Asprin (100mg) plus cilostazol (200mg)
    Description: Asprin (100mg) plus cilostazol (200mg)
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Asprin (100mg) plus placebo
    ARM 1: Kind: Experimental
    Label: Asprin (100mg) plus placebo
    Description: Asprin (100mg) plus placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Initial assessment of all patients will include vital signs, risk factors, TCD, and laboratory data, with TCD and laboratory data repeated at 14 and 90 days. Participants are randomized to receive either cilostazole or placebo (100mg tablets twice daily, orally). Aspirin (100mg once daily) is given to all the participants.

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes of pulsatility indices (PIs).
Secondary Sroke recurrence at 90 days.
Primary The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study 14 days and 90 days from the baseline TCD study No
Secondary Number of Patients With First Recurrent Stroke of Any Type 90 days No

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