ACCEL-LOADING-ACS Study

Gyeongsang National University Hospital

Status and phase: Completed; Phase 4

Conditions: Anti-inflammatory Agent; Myocardial Reperfusion Injury; Platelet Aggregation Inhibitors

Treatments: Drug: Dual Anti-Platelet Therapy (DAPT); Drug: Triple Anti-Platelet Therapy (TAPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01354808

ACCEL-LOADING

Details and patient eligibility

About

The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).

Full description

In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years of age
• Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization

Exclusion criteria

• ST segment elevation acute myocardial infarction
• NSTE ACS with high-risk features warranting emergency coronary angiography
• Oral anticoagulation therapy with warfarin
• Use of pre-procedural glycoprotein IIb/IIIa inhibitor
• Contraindication to antiplatelet therapy
• AST or ALT ≥ 3 times upper normal
• Left ventricular ejection fraction < 30%
• WBC < 3,000/mm3, platelet < 100,000/mm3
• Creatinine ≥ 3 mg/dl
• stroke within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

DAPT

Active Comparator group

Treatment:

Drug: Dual Anti-Platelet Therapy (DAPT)

TAPT

Experimental group

Treatment:

Drug: Triple Anti-Platelet Therapy (TAPT)