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CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study (CALDERA-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876512
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : September 10, 2014
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University

Brief Summary:
Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. The present study is designed in order to clarify the influence of CYP2C19 genetic polymorphism on the several biomarkers for platelet activation in Japanese patients treated with thienopyridines undergoing elective PCI.

Condition or disease
Stable Angina

Detailed Description:
We enrolled patients with stable effort angina who received dual-antiplatelet therapy with both aspirin (100mg) and clopidogrel (75mg). We performed PCI 12-24 hours after 300mg loading dose of clopidogrel, or at least 7 days of 75mg clopidogrel treatment after 300mg initial loading dose. We examined platelet adhesiveness, plasma biomarkers for platelet activation such as plasma VWF and ADAMTS13, CD40L, P-Selectin levels, and ADP-induced platelet aggregation using Light transmittance aggregometry (LTA) and VerifyNow P2Y12 assay system in those patients. We also analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation.

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Platelet function tests [ Time Frame: before, immediately after, 1, 2, and 28 days after elective PCI ]
    Platelet function tests and assays for blood biomarkers of coagulation activation and inflammation before, immediately after, 1, 2, and 28 days after elective PCI.

Biospecimen Retention:   Samples With DNA
CYP2C19 gene alteration is measured by using whole blood in patients with stable effort angina undergoing PCI.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Kumamoto University Hospital, Kumamoto Chuo Hospital and Saisekai Kumamoto Hospital

Inclusion Criteria:

  • The stable effort angina patients
  • More than 20 years old
  • Undergoing elective PCI treated with aspirin and clopidogrel

Exclusion Criteria:

  • Patients treated with the following medical therapy (ie. Warfarin, Steroid, thrombolytic drug, Ticlopidine, Sarpogrelate hydrochloride or Cilostazol)
  • Patients with the following diseases (deep vein thrombosis, atrial fibrillation, collagen disease, infection, liver or renal dysfunction, malignant diseases)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876512

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Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
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Responsible Party: Hisao Ogawa, Professor, Department of Cardiovascular Medicine, Kumamoto University Identifier: NCT00876512    
Other Study ID Numbers: 0124
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by Hisao Ogawa, Kumamoto University:
thienopyridine resistance
stable effort angina
platelet activation
von Willebrand Factor
Additional relevant MeSH terms:
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Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms