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Completed

NCT Number: NCT01094457

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

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Clopidogrel Low Responsiveness Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

463 Hospital of PLA, Shenyang, Liaoning, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

l:

  • 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

Treatment and study plan

Aspirin, Clopidogrel

Drug

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

aspirin, clopidogrel, cilostazol

Drug

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 outcomes

  1. Major ischemic cardiovascular events

    Time frame: 1 year

    defined as a composite of cardiac death, myocardial infarction or stroke

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2010
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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