NCT00938522

Brief Summary

The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

1.4 years

First QC Date

July 13, 2009

Last Update Submit

July 20, 2009

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Cilostazol loadingAngioplasty, Transluminal, Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)

    at 3 months after PCI

Secondary Outcomes (3)

  • Late loss on quantitative coronary angiography

    9 months after index PCI

  • % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS

    9 months after index PCI

  • Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)

    12 months after index PCI

Study Arms (2)

Cilostazol loading

EXPERIMENTAL
Drug: Cilostazol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CilostazolDRUG

Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.

Cilostazol loading
PlaceboDRUG

Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective PCI
  • Presence of coronary lesions amenable to stent

You may not qualify if:

  • Cardiogenic shock
  • Urgent PCI
  • Hypersensitivity to aspirin, clopidogrel, or cilostazol
  • LVEF \< 30% or congestive heart failure
  • Bleeding diathesis
  • leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3
  • aspartate aminotransferase or alanine aminotransferase \> 3 times upper normal; serum creatinine \> 2.0 mg/dl
  • noncardiac disease with a life expectancy \< 1 year
  • inability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Hyeon-Cheol Gwon, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeon-Cheol Gwon, MD, PhD

CONTACT

82-2-3410-3418hc.gwon@samsung.com

Young Bin Song, MD, PhD

CONTACT

82-2-3410-1333youngbin.song@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

October 1, 2011

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

KR(1)