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

Percutaneous Coronary Intervention Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094457
• Other study ID #: 825004-5
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2010
• Last updated: June 13, 2012
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Clopidogrel Low Responsiveness
• Percutaneous Coronary Intervention

Intervention

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
• 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.

Locations

Country	Name	City	State
China	463 Hospital of PLA	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Shenyang Northern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major ischemic cardiovascular events	defined as a composite of cardiac death, myocardial infarction or stroke	1 year	No
Secondary	Stent thrombosis	according to ARC definition	1 year	Yes
Secondary	major adverse cardiac and cerebral events(MACCE)	defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke	1 year	No
Secondary	Hemorrhagic events	according to TIMI bleeding definition	within 1 year	Yes
Secondary	reduction in ADP induced platelet aggregation	assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)	30 days	No