Clinical trial NCT00947843: Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
Official title: Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: CHD
CHD equivalents
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: CKD Pharmaceutical Limited
First posted: 2009-07-28
Enrollment: 306
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.


Eligibility criteria: Inclusion Criteria:

* Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
* Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
* History of PCI or coronary artery bypass graft surgery (CABG) \> one year or
* Diabetes mellitus (including type I and type II) or
* Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
* History of peripheral artery disease or
* History of cerebrovascular disease

Exclusion Criteria:

* Patients who had history of PCI within one year
* Patients who used concomitant anticoagulants
* Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
* Chronic alcoholism or drug addiction
* Women who were pregnant or breastfeeding or who were not using an effective method of contraception
* The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug

Primary outcomes:
measure: The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events after study medication
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ki-Bae Seung, MD, PhD
role: STUDY_DIRECTOR
affiliation: Gyeongsang National University Hospital
name: Chung-Hwan Gwak, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kyung Hee University Hospital
name: Kwon-Sam Kim, MD,PhD
role: STUDY_DIRECTOR
affiliation: Korea University Anam Hospital
name: Soon-Jun Hong, MD,PhD
role: STUDY_DIRECTOR
affiliation: Dong-A medical center
name: Tae-Ho Park, MD,PhD
role: STUDY_DIRECTOR
affiliation: Seoul Metropolitan Boramae Hospital
name: Sang-Hyun Kim, MD,PhD
role: STUDY_DIRECTOR
affiliation: Ajou University Medical Center
name: Seung-Jea Tahk, MD,PhD
role: STUDY_DIRECTOR
affiliation: Jeju National University Hospital
name: Seung-Jae Joo, MD,PhD
role: STUDY_DIRECTOR
affiliation: Hallym University Medical Center
name: Young-Jin Choi, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Suh JW, Seung KB, Gwak CH, Kim KS, Hong SJ, Park TH, Kim SH, Choi YJ, Joo SJ, Tahk SJ, Kim HS. Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial. Clin Ther. 2011 Aug;33(8):1057-68. doi: 10.1016/j.clinthera.2011.07.001. Epub 2011 Aug 4.