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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00876512
First received: April 3, 2009
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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
Stable Angina

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • Platelet function tests [ Time Frame: before, immediately after, 1, 2, and 28 days after elective PCI ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Kumamoto University Hospital, Kumamoto Chuo Hospital and Saisekai Kumamoto Hospital

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876512

Locations
Japan
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
  More Information

No publications provided

Responsible Party: Hisao Ogawa, Professor, Department of Cardiovascular Medicine, Kumamoto University
ClinicalTrials.gov Identifier: NCT00876512     History of Changes
Other Study ID Numbers: 0124
Study First Received: April 3, 2009
Last Updated: September 8, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Kumamoto University:
thienopyridine resistance
stable effort angina
platelet activation
ADAMTS13
von Willebrand Factor

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014