Cilostazol and Endothelial Progenitor Cell (EPISODE)

Gyeongsang National University Hospital

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction, Acute

Treatments: Drug: Cilostazol Tablets; Drug: placebo; Drug: Aspirin; Drug: Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04407312

GNUHIRB 2012-01-005

Details and patient eligibility

About

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)

Full 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)

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

CILO group

Experimental group

Description:

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.

Treatment:

Drug: Clopidogrel

Drug: Aspirin

Drug: Cilostazol Tablets

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Clopidogrel

Drug: placebo

Drug: Aspirin