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Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT00404781
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Shenyang Northern Hospital

Brief Summary:
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Acute Coronary Syndromes Drug: cilostazol in addition to aspirin and clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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Arm Intervention/treatment
Experimental: optimal antiplatelet
cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance
Drug: cilostazol in addition to aspirin and clopidogrel
Active Comparator: standard antiplatelet
aspirin and clopidogrel for all patients
Drug: cilostazol in addition to aspirin and clopidogrel



Primary Outcome Measures :
  1. Major adverse cardiac and cerebral events at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Hemorrhage events at 1 year [ Time Frame: 1 year ]


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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
Criteria

Inclusion Criteria:

  • non-ST-segment elevated acute coronary syndromes
  • patients undergoing selective or emergent PCI

Exclusion Criteria:

  • administration of clopidogrel or ticlopidine within 2 weeks
  • ST-segment elevated myocardial infarction
  • contraindications of antiplatelet therapy
  • history of intracranial bleeding
  • known bleeding disorders
  • severe liver or kidney disease

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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): NCT00404781


Locations
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China, Liaoning
Northern Hospital
Shenyang, Liaoning, China, 110016
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
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Principal Investigator: Yaling Han, M.D. Shenyang Northern Hospital

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Responsible Party: Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT00404781     History of Changes
Other Study ID Numbers: NH-2006-C001
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Shenyang Northern Hospital:
ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
platelet function
aspirin
clopidogrel
cilostazol

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Heart Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Syndrome
Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cilostazol
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