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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01094457
First received: March 26, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Coronary Syndromes
Percutaneous Coronary Intervention
Clopidogrel Low Responsiveness
 Drug: aspirin, clopidogrel
Drug: aspirin, clopidogrel, cilostazol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Major ischemic cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined as a composite of cardiac death, myocardial infarction or stroke


Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    according to ARC definition

  • major adverse cardiac and cerebral events(MACCE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke

  • Hemorrhagic events [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]
    according to TIMI bleeding definition

  • reduction in ADP induced platelet aggregation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)


Enrollment: 840
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094457

Locations
China, Liaoning
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110840
463 Hospital of PLA
Shenyang, Liaoning, China, 110000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110016
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Yaling Han, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01094457     History of Changes
Other Study ID Numbers: 825004-5
Study First Received: March 26, 2010
Last Updated: June 13, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aspirin
Cilostazol
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013