Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation

Sponsor

Shenyang Northern Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00404716

Collaborator

(none)

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Cilostazol	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Triple Versus Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Undergoing Coronary Stent Implantation

Study Start Date :

Dec 1, 2004

Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Shenyang Northern Hospital

Investigators

Principal Investigator: Yaling Han, Dr., Shenyang Northern Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00404716

Other Study ID Numbers:

NH-2006-A006

First Posted:

Nov 29, 2006

Last Update Posted:

Nov 29, 2006

Last Verified:

Nov 1, 2006

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Cilostazol

Study Results

No Results Posted as of Nov 29, 2006