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

Information source: Shenyang Northern Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness

Intervention: aspirin, clopidogrel (Drug); aspirin, clopidogrel, cilostazol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shenyang Northern Hospital

Official(s) and/or principal investigator(s):
Yaling Han, MD, Principal Investigator, Affiliation: Shenyang Northern Hospital

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.

Clinical Details

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

Primary outcome: Major ischemic cardiovascular events

Secondary outcome:

Stent thrombosis

major adverse cardiac and cerebral events(MACCE)

Hemorrhagic events

reduction in ADP induced platelet aggregation

Eligibility

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

463 Hospital of PLA, Shenyang, Liaoning 110000, China

Shengjing Hospital of China Medical University, Shenyang, Liaoning 110016, China

Shenyang Northern Hospital, Shenyang, Liaoning 110840, China

Additional Information

Starting date: March 2009
Last updated: June 13, 2012

Page last updated: August 23, 2015

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