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

Primary Purpose

Acute Coronary Syndromes, Percutaneous Coronary Intervention, Clopidogrel Low Responsiveness

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
aspirin, clopidogrel
aspirin, clopidogrel, cilostazol
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring antiplatelet therapy, clopidogrel low responsiveness, acute coronary syndromes, percutaneous coronary intervention, cilostazol

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 463 Hospital of PLA
  • Shengjing Hospital of China Medical University
  • Shenyang Northern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard group

intensive group

Arm Description

patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d

patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA

Outcomes

Primary Outcome Measures

Major ischemic cardiovascular events
defined as a composite of cardiac death, myocardial infarction or stroke

Secondary Outcome Measures

Stent thrombosis
according to ARC definition
major adverse cardiac and cerebral events(MACCE)
defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
Hemorrhagic events
according to TIMI bleeding definition
reduction in ADP induced platelet aggregation
assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)

Full Information

First Posted
March 26, 2010
Last Updated
June 13, 2012
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01094457
Brief Title
Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes, Percutaneous Coronary Intervention, Clopidogrel Low Responsiveness
Keywords
antiplatelet therapy, clopidogrel low responsiveness, acute coronary syndromes, percutaneous coronary intervention, cilostazol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard group
Arm Type
Active Comparator
Arm Description
patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d
Arm Title
intensive group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
aspirin, clopidogrel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
aspirin, clopidogrel, cilostazol
Intervention Description
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 Measure Information:
Title
Major ischemic cardiovascular events
Description
defined as a composite of cardiac death, myocardial infarction or stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Stent thrombosis
Description
according to ARC definition
Time Frame
1 year
Title
major adverse cardiac and cerebral events(MACCE)
Description
defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
Time Frame
1 year
Title
Hemorrhagic events
Description
according to TIMI bleeding definition
Time Frame
within 1 year
Title
reduction in ADP induced platelet aggregation
Description
assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
463 Hospital of PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Shenyang Northern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110840
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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