Clopidogrel Maintaining Dosage in Acute Coronary Syndrome After Drug Eluting Stent Implantation
Information source: Shenyang Northern Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Clopidogrel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shenyang Northern Hospital Official(s) and/or principal investigator(s):
Yaling Han, Dr, Principal Investigator, Affiliation: Shenyang Northern Hospital
Summary
In view of its safety profile and the results of clinical trials, clopidogrel has become the
standard treatment for patients with acute coronary syndrome (ACS) and drug eluting
stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with
clopidogrel had beneficial effects. The pretreatment regimens were given a mean of 6 days
before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO
trial respectively. Accordingly, current clinical practice carries out pretreatment with a
300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients
with ACS. Compared with the 300mg clopidogrel loading dose, 600mg loading dose exhibited a
superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing
DES implantation for ACS according to recent a few publications. But despite clopidogrel
600mg loading dose and the routine use of 75mg per day as a maintaining dose, recurrent
ischemic events occurred in some patients. Therefore, the goal of this study will evaluate
the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose
in patients with ACS undergoing DES implantation.
ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel
pretreatment are eligible for the study. All enrolled patients will be randomized to receive
daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI, in
addition to daily aspirin 100 mg, and lasted for the first month after DES implantation. One
month later, all patients receive daily clopidogrel 75mg until 9~12month after DES
implantation. The primary endpoints include death of all causes, myocardial infarction,
revascularization of the target lesson, sub-acute and late stent thrombosis one year after
PCI, The secondary endpoints are major and minor bleeding events. The study will be powered
to test the hypothesis that higher maintaining dose(150mg) of clopidogrel will reduce major
adverse cardiac events compared to currently used common dose(75 mg) at one year following
PCI.
Clinical Details
Official title: One Year Effects of Different Clopidogrel Maintaining Dosage on Patients With Acute Coronary Syndrome Undergoing Coronary Drug Eluting Stent Implantation
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with ACS and planned pretreatment with 600mg loading dose of commercially
available clopidogrel (Plavix).
- between ages of 18 Years and above
- Presence of one or several stenosis in native coronary arteries requiring PCI and
suitable for DES implantation.
- Willing and able to sign informed consent.
Exclusion Criteria:
- A history of bleeding diathesis.
- New York Heart Association functional class IV.
- Prior PCI or coronary bypass grafting < 3 months.
- contraindications to clopidogrel and aspirin (White blood cells counts < 4×109/L or
platelet counts <100 g. l-1 ;creatinine clearance <25 ml • min-1 ;active liver
disease).
- use of glycoprotein IIb/IIIa inhibitors before PCI.
Locations and Contacts
Additional Information
Starting date: December 2004
Ending date: November 2006
Last updated: November 28, 2006
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