Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

NCT ID: NCT00938522

Last Updated: 2009-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Angioplasty, Transluminal, Percutaneous Coronary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cilostazol loading

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilostazol

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Samsung Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyeon-Cheol Gwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyeon-Cheol Gwon, MD, PhD

Role: CONTACT

82-2-3410-3418

Young Bin Song, MD, PhD

Role: CONTACT

82-2-3410-1333

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hyeon-Cheol Gwon, MD, PhD

Role: primary

82-2-3410-3418

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-06-031

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.