NCT01188824

Brief Summary

The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 7, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

August 23, 2010

Last Update Submit

September 30, 2013

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint for this study is slowdown of PAD progression based on ABI.

    2 years

Secondary Outcomes (1)

  • Carotid intima-media thickness

    2 years

Study Arms (2)

Cilostazol

ACTIVE COMPARATOR

Pletaal® (Cilostazol) 100 mg, bid p.o.

Drug: Cilostazol

placebo

PLACEBO COMPARATOR

Placebo 1 tablet, bid p.o.

Other: placebo

Interventions

CilostazolDRUG

100 mg, bid p.o.

Also known as: Pletaal®
Cilostazol
placeboOTHER

1 tablet, bid

placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
  • Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
  • PAD (i.e. ankle-brachial index or ABI \<1.0)

You may not qualify if:

  • Patients unable to give informed consent
  • Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
  • Modified Rankin Scale \>4
  • Patients with history of dementia requiring institutional care
  • Known brain tumor
  • Known anemia (defined as hemoglobin \<10.0 g/dL)
  • Known thrombocytopenia (defined as platelet count below 100,000/cm3)
  • AST or ALT \> 3 x Upper Normal Limit
  • Calculated creatinine clearance \< 30 ml/min according to the Copckroft formula)
  • Known hemostasis or coagulation disorder
  • Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
  • Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
  • Symptomatic PAD requiring treatment with cilostazol
  • Known stenosis of the upper limb arteries that may affect the documentation of ABI
  • Patients with known hypersensitivity to cilostazol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chung Y. Hsu, MD. Ph.D.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 26, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-07