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Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094457
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Yaling Han, Shenyang Northern Hospital

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE March 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
Major ischemic cardiovascular events [ Time Frame: 1 year ]
defined as a composite of cardiac death, myocardial infarction or stroke
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
  • Stent thrombosis [ Time Frame: 1 year ]
    according to ARC definition
  • major adverse cardiac and cerebral events(MACCE) [ Time Frame: 1 year ]
    defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
  • Hemorrhagic events [ Time Frame: within 1 year ]
    according to TIMI bleeding definition
  • reduction in ADP induced platelet aggregation [ Time Frame: 30 days ]
    assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
Official Title  ICMJE Not Provided
Brief Summary Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndromes
  • Percutaneous Coronary Intervention
  • Clopidogrel Low Responsiveness
Intervention  ICMJE
  • Drug: aspirin, clopidogrel
    patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year
  • Drug: aspirin, clopidogrel, cilostazol
    Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.
Study Arms  ICMJE
  • Active Comparator: standard group
    patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d
    Intervention: Drug: aspirin, clopidogrel
  • Experimental: intensive group
    patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA
    Intervention: Drug: aspirin, clopidogrel, cilostazol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2012)
840
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
800
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criterial:

  • aged 35 to 75 years
  • acute coronary syndromes
  • underwent successful coronary stent implantation
  • informed consent

Exclusion Criteria:

  • contraindications to antiplatelet therapy
  • history of intracranial bleeding
  • known bleeding disorders
  • severe liver or kidney disease
  • pregnancy
  • left main coronary artery disease
  • planned non cardiac surgery within 1 year
  • end stage of other serious disease with life expectancy less than 1 year
  • heart failure with NYHA grade 3 to 4
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094457
Other Study ID Numbers  ICMJE 825004-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yaling Han, Shenyang Northern Hospital
Study Sponsor  ICMJE Shenyang Northern Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
PRS Account Shenyang Northern Hospital
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP