Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients (SILOAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Korea University Guro Hospital
Sponsor:
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT01261832
First received: December 16, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: antiplatelet therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Prospective , Open Label, Phase 4 Trial of Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention With Drug-eluting Stent

Resource links provided by NLM:


Further study details as provided by Korea University Guro Hospital:

Primary Outcome Measures:
  • Major Adverse Cardiovascular and Cerebral Events [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Composite of total death, Nonfatal Myocardial Infarction (Non-QMI , Q-MI), Repeat RevascularizationI (Target Vessel Revascularization +Non Target Vessel Revascularization , Coronary Artery Bypass Graft), Stroke (Ischemic & Hemorrhagic)


Secondary Outcome Measures:
  • Individual outcome of primary end points, Stent thrombosis,Bleeding Complication,PFT (Platelet function test),Genotyping results [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    1. Individual outcome of primary end points
    2. Stent thrombosis
    3. Beeding Complication defined by the TIMI criteria & Minor Bleeding, Vascular Complications
    4. Angiographic outcomes at 1 year : Binary restenosis, Late loss, FU MLD, mean % restenosis, restenosis type
    5. IVUS findings at Index and Follow up angiography
    6. PFT (Platelet function test) : at discharge, intercurrent event , after one year
    7. Genotyping results : genetic polymorphism


Estimated Enrollment: 951
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual antiplatelet therapy for 1 year
Dual antiplatelet therapy for 1 year : dual antiplatelet combination therapy with aspirin and clopidogrel for 1 year
Drug: antiplatelet therapy
Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.
Other Names:
  • The brand name of clopidogrel is Plavix.
  • The brand name of cilostazol is Pletaal.
Experimental: Triple antiplatelet therapy for 1 month
Triple antiplatelet therapy for 1 month : triple antiplatelet therapy including cilostazol for 1 month and after then, dual antiplatelet therapy for 11 months
Drug: antiplatelet therapy
Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.
Other Names:
  • The brand name of clopidogrel is Plavix.
  • The brand name of cilostazol is Pletaal.
Experimental: Triple antiplatelet therapy for 6 months
Triple antiplatelet therapy for 6 months : triple antiplatelet combination therapy including cilostazol for 6 months and after then, dual antiplatelet therapy for 6 months and cilostazol
Drug: antiplatelet therapy
Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.
Other Names:
  • The brand name of clopidogrel is Plavix.
  • The brand name of cilostazol is Pletaal.

Detailed Description:

Drug-eluting stents (DES) have drastically changed the landscape of percutaneous coronary intervention (PCI), with significant reductions in the angiographic restenosis rate and need for repeated revascularization. However, several studies showed that DES is associated with a higher incidence of in-stent thrombosis compared with bare metal stents. Therefore, the latest guideline for antiplatelet therapy after PCI with DES suggests that the dual antiplatelet therapy (aspirin plus clopidogrel) be administered for at least 12 months.But is it enough for high-risk patients? Some studies showed that as many as 50% of the patients who received PCI did not react positively to aspirin or clopidogrel.Furthermore, there is increased platelet activity in acute coronary syndrome, especially in acute myocardial infarction (AMI). compared with aspirin or clopidogrel.A recent study suggested that cilostazol could ameliorate platelet responsiveness to clopidogrel in patients who underwent primary PCI. Furthermore, some other studies showed that the administration of cilostazol after PCI could significantly lower the incidence of in-stent restenosis. Therefore, the present study is designed to evaluate the safety and efficacy of additional administration of cilostazol with aspirin and clopidogrel in a real-world cardiology practice among patients presenting with AMI who received primary PCI with DES.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Acute Myocardial Infarction Undergoing Primary percutaneous coronary intervention.

Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol
  2. Uncontrolled hypertension
  3. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
  4. Baseline hemogram with Hb<10g/dL or PLT count<100,000/μL
  5. Patients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel
  6. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  7. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261832

Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Woon Rha, PhD, MD    82-2-818-6387    swrha617@yahoo.co.kr   
Principal Investigator: Seung Woon Rha, Profession         
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Principal Investigator: Seung Woon Rha, MD. PhD. Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
  More Information

Publications:
Responsible Party: Seung Woon Rha, Associate professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT01261832     History of Changes
Other Study ID Numbers: KoreaUGuroH SILOAM
Study First Received: December 16, 2010
Last Updated: January 28, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University Guro Hospital:
Acute Myocardial Infarction
Percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Cilostazol
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014