Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

Study Overview
=================
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.

Official Title
-----------------
PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events

Conditions
-----------------
Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
-----------------
* Drug: Cilostazol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilostazol loading<br> | Drug: Cilostazol<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) |  | at 3 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cilostazol loading, Angioplasty, Transluminal, Percutaneous Coronary