Cilostazol and Endothelial Progenitor Cell

Myocardial Infarction, Acute Clinical Trial

— EPISODE  

Official title:

Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients With Acute Myocardial Infarction: A Randomized, Placebo-controlled ACCEL-EPISODE Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04407312
• Other study ID #: GNUHIRB 2012-01-005
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2020
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization in patients with acute myocardial infarction (To reveal the role of cilostazol in up-regulation of EPC count)

Description:

Primary endpoint: % Change of EPC count

Secondary endpoints:

1. Changes of ADP/AA/collagen-induced PFT

2. Changes of lipid profile and high sensitivity-C-reactive protein

3. Change of TEG measurements

4. Change of PWV

5. Predictors of EPC count (baseline and 1-month)

6. ischemic (CV death, MI & stroke) and bleeding events (BARC)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• naïve AMI

• undergoing successful coronary stent implantation

Exclusion Criteria:

• high-risk patients for thrombotic event;

• a history of active bleeding or bleeding diatheses;

• contraindication to antiplatelet therapy;

• hemodynamic or electrical instability;

• oral anticoagulation therapy;

• left ventricular ejection fraction < 30%;

• leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3;

• AST or ALT > 3 times the respective the upper limit;

• serum creatinine level > 3.5 mg/dL;

• stroke within 3 months;

• pregnancy;

• non-cardiac disease with a life expectancy < 1 year;

• any patients not tolerable or suitable for coronary intervention; and

• inability to follow the protocol

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Drug:
• Cilostazol Tablets
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
• placebo
Placebo, tablet, 200mg, once daily, 30 days.
• Aspirin
Astrix, capsule,100mg, once daily, 30 days.
• Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital	Korea Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline CD133+/KDR+ at 30 days	Peripheral blood mononuclear cells measurement by flow cytometry	baseline and 30 days
Primary	Changes from baseline CD34+/KDR+ at 30 days	Peripheral blood mononuclear cells measurement by flow cytometry	baseline and 30 days
Secondary	Levels of Platelet inhibition	Platelet function test by VerifyNow assay at 30-day follow-up	baseline and 30 days
Secondary	Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method	the correlation between the changes of EPC subsets and ?Platelet reactivity unit (PRU) by Pearson's method	baseline and 30 days
Secondary	Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow	the correlation between the changes of EPC subsets and ?PRU by Pearson's method	baseline and 30 days
Secondary	Incidence of bleeding events by BACR definition	Safety outcome	30 days