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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. Identifier: NCT01094457
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
Yaling Han, Shenyang Northern Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Percutaneous Coronary Intervention Clopidogrel Low Responsiveness Drug: aspirin, clopidogrel Drug: aspirin, clopidogrel, cilostazol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: standard group
patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d
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

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
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.

Primary Outcome Measures :
  1. Major ischemic cardiovascular events [ Time Frame: 1 year ]
    defined as a composite of cardiac death, myocardial infarction or stroke

Secondary Outcome Measures :
  1. Stent thrombosis [ Time Frame: 1 year ]
    according to ARC definition

  2. 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

  3. Hemorrhagic events [ Time Frame: within 1 year ]
    according to TIMI bleeding definition

  4. reduction in ADP induced platelet aggregation [ Time Frame: 30 days ]
    assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094457

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China, Liaoning
463 Hospital of PLA
Shenyang, Liaoning, China, 110000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110016
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110840
Sponsors and Collaborators
Shenyang Northern Hospital
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Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
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Responsible Party: Yaling Han, vice president, Shenyang Northern Hospital Identifier: NCT01094457    
Other Study ID Numbers: 825004-5
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Keywords provided by Yaling Han, Shenyang Northern Hospital:
antiplatelet therapy
clopidogrel low responsiveness
acute coronary syndromes
percutaneous coronary intervention
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents