Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation

November 28, 2006 updated by: Shenyang Northern Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

February 1, 2007

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

November 29, 2006

Last Update Submitted That Met QC Criteria

November 28, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH-2006-A006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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