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Completed

NCT Number: NCT00876512

CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Acronym: CALDERA-PCI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 6, 2009
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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