Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation
Information source: Shenyang Northern Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Cilostazol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shenyang Northern Hospital Official(s) and/or principal investigator(s):
Yaling Han, Dr., Principal Investigator, Affiliation: Shenyang Northern Hospital
Summary
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.
Clinical Details
Official title: Effects of Triple Versus Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Undergoing Coronary Stent Implantation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2004
Ending date: February 2007
Last updated: November 28, 2006
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