Cilostazol and Endothelial Progenitor Cell

NCT04407312 | Unknown Phase 4

• 1 other identifier: GNUHIRB 2012-01-005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Myocardial Infarction, Acute

Keywords

Endothelial progenitor cell; Myocardial infarction, acute; Platelets; Cilostazol

Outcome Measures

Primary Outcomes (2)

• Changes from baseline CD133+/KDR+ at 30 days

  Peripheral blood mononuclear cells measurement by flow cytometry

  baseline and 30 days

• Changes from baseline CD34+/KDR+ at 30 days

  Peripheral blood mononuclear cells measurement by flow cytometry

  baseline and 30 days

Secondary Outcomes (4)

• Levels of Platelet inhibition

  baseline and 30 days

• Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method

  baseline and 30 days

• Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow

  baseline and 30 days

• Incidence of bleeding events by BACR definition

  30 days

Study Arms (2)

CILO group

EXPERIMENTAL

Intervention: Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room. After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence. For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily). Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial. Drug: Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.

Drug: Cilostazol Tablets; Drug: Aspirin; Drug: Clopidogrel

Placebo group

PLACEBO COMPARATOR

Intervention: Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room. After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence. In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily). Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial. Drug: Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.

Drug: placebo; Drug: Aspirin; Drug: Clopidogrel

Interventions

Cilostazol Tablets DRUG

Cilostazol-SR, capsule, 200mg, once daily, 30 days.

Also known as: Cilostazol-SR

CILO group

placebo DRUG

Placebo, tablet, 200mg, once daily, 30 days.

Placebo group

Aspirin DRUG

Astrix, capsule,100mg, once daily, 30 days.

Also known as: Astrix

CILO group; Placebo group

Clopidogrel DRUG

Plavix, tablet, 75mg, once daily, 30 days.

Also known as: Plavix

CILO group; Placebo group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• naïve AMI
• undergoing successful coronary stent implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Gyeongsang National University Hospital: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Related Publications (1)

• Park Y, Kim JH, Kim TH, Koh JS, Hwang SJ, Hwang JY, Jeong YH. Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial. J Clin Med. 2020 Jun 1;9(6):1678. doi: 10.3390/jcm9061678.

  PMID: 32492942 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Cilostazol; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines

Study Officials

• Young-Hoon Jeong, MD,.PhD

  Gyeongsang National University Changwon Hospital

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 29, 2020
• Study Start: January 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: July 31, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share