Clinical trial NCT02060786: Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Official title: Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Antiplatelet; clopidogrel; acute coronary syndrome
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical
First posted: 2014-02-12
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

1. Patients with unstable angina or non-ST elevation myocardial infarction
2. Patients who are planned coronary angiography
3. Age \>18 years, \<75 years
4. Patients who agree to the study protocol

Exclusion Criteria:

1. Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
2. Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
3. Allergy to antiplatelet agent
4. Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
5. History of drug abuse or alcohol abuse
6. ST elevation myocardial infarction
7. Pregnancy
8. Low platelet count (\< 100,000 /L) or abnormal results of PT or PTT
9. Liver disease ( bilirubin \> 2 mg/dL, AST or ALT \> 100 IU)
10. Renal failure ( Cr \> 2.0 mg/dL)
11. Malignancy
12. Proton pump inhibitor, NSAIDs statin (except atorvastatin)

Primary outcomes:
measure: PRU level at 2 hours after clopidogrel loading
timeFrame: 2 hours after clopidogrel loading
Secondary outcomes:
measure: PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
timeFrame: 4 -, 8- and 24 hours after clopidogrel loading
measure: ARU level by VerifyNow before and 2 hours after loading
timeFrame: 2 hours after loading
measure: Composite of death, myocardial infarction, target vessel revascularization
timeFrame: at 30 days
measure: Stent thrombosis by Academic Research Consortium definition
timeFrame: at 30 days
measure: Incidence of TIMI major bleedings
timeFrame: at 30 days
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
citation: Seo KW, Tahk SJ, Yang HM, Yoon MH, Shin JH, Choi SY, Lim HS, Hwang GS, Choi BJ, Park JS, Shin JS, Lee YH, Choi YW, Park SJ, Jin XJ. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014 Nov 1;36(11):1588-94. doi: 10.1016/j.clinthera.2014.07.018. Epub 2014 Sep 15.