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Related Studies
Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation
This study has been completed.
First Received: November 28, 2006   No Changes Posted
Sponsor: Shenyang Northern Hospital
Information provided by: Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT00404716
  Purpose

Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that selectively inhibits phosphodiesterase III, a mechanism different from adenosine diphosphate (ADP) receptor antagonists. Previous studies had suggested that cilostazol has lipid-modifying and vasodilating effects in addition to antiplatelet effects. From those experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of atherothrombosis complications following coronary stenting. Therefore, we evaluated the safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute coronary syndrome undergoing successful coronary artery stenting.

Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy (aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus cilostazol) groups. All enrolled patients in triple regimen group will receive cilostazol 100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and clopidogrel for post-PCI. The primary endpoints included death, myocardial infarction, target lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and major adverse cardiac events (MACE) at one year. The secondary endpoints were side effects of study drugs, including major bleeding, vascular complication, hypersensitivebility, and bleeding complications. The study will be powered to test the hypothesis that triple antiplatelet therapy is better than dual antiplatelet therapy.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Cilostazol
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effects of Triple Versus Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Undergoing Coronary Stent Implantation

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Study Start Date: December 2004
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with ACS Undergoing coronary stent implantation
  • Between ages of above 18 Years and bellow 80 Years.
  • Presence of one or several stenosis in native coronary arteries requiring PCI.
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • A history of bleeding diathesis.
  • New York Heart Association functional class IV.
  • Prior PCI or coronary bypass grafting < 3 months.
  • Contraindications to clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g.l-1 ;creatinine clearance <25 ml • min-1 ;active liver disease).
  • Use of glycoprotein IIb/IIIa inhibitors before PCI.
  • Preparing to undergo CABG
  • Taken clopidogrel or cilostazol recently
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404716

Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, Dr. Shenyang Northern Hospital
  More Information

No publications provided

Study ID Numbers: NH-2006-A006
Study First Received: November 28, 2006
Last Updated: November 28, 2006
ClinicalTrials.gov Identifier: NCT00404716     History of Changes
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Cilostazol
Heart Diseases
Disease
Vascular Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010