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

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ClinicalTrials.gov Identifier: NCT01094457
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : April 2012
Study Completion Date : June 2012

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U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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)


Eligibility Criteria

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

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
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT01094457


Locations
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
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
More Information

Responsible Party: Yaling Han, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01094457     History of Changes
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
cilostazol

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Ticlopidine
Cilostazol
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors