Synergistic Effect of Combination Therapy With Cilostazol and Probucol on Plaque Stabilization and Lesion Regression: Serial Intravascular Ultrasound and Virtual Histology Study(SECURE Study)

Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031667
• Other study ID #: 4-2009-0489
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2009
• Last updated: June 16, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of combination therapy with cilostazol and probucol on plaque volume and composition change in comparison with cilostazol alone by serial intravascular ultrasound and virtual histology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients treated with PCI with stent

2. Male or female over 20 years of age

3. Presence of at least one PCI target lesion(lesion length =26mm) with =50% diameter stenosis that can be covered with a single Endeavor Sprint stent(Medtronic)

4. Other PCI target lesions also should be treated with Endeavor Sprint stents

5. Presence of an intermediate non-PCI target lesion with luminal narrowing of =30% and =70% by visual estimation

6. Signed written informed consent to participate in the study

Exclusion Criteria:

1. Intermediate (non-PCI target) lesions that might provide difficulty for IVUS evaluation because of following reasons: heavy calcification (>90° Arc), tortuous vessel with sever angulation, total occlusion, or bifurcation lesions

2. Previous PCI in the last 6 months

3. Previous CABG

4. Patients with AMI undergoing primary PCI or rescue PCI after thrombolysis

5. Cardiogenic shock

6. Inability to take adequate anti-platelet therapy

7. Thrombocytopenia (platelet count <70 x 109/l)

8. Known hypersensitivity or contraindication to any of the following medications:

Heparin, aspirin, clopidogrel, cilostazol, probucol, statin, contrast media*

*Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.

9. History of severe ventricular arrhythmia

10. Significant QTc prolongation (=470 ms) on ECG

11. NYHA class III/IV heart failure or LV ejection fraction =35%

12. Familial hypercholesterolemia

13. Uncontrolled hypertriglyceridemia (>400 mg/dL)

14. Chronic renal failure with serum creatinine level =2mg/dL

15. Severe liver disease or transaminase level =3 times the upper limit of normal.

16. Pregnant or breastfeeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Therapy

Intervention

Drug:
• Cilostazol, Probucol / placebo of probucol
An investigator-initiated, placebo-controlled, randomized, multi-center study. Enrolled patients will be randomized after PCI either to the combination therapy group or to the control group. In the combination therapy group, cilostazol 200 mg and probucol 500 mg will be administered daily, whereas the control group will receive cilostazol 200 mg daily only.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion)		From February 01, 2009 to July 31, 2011	No