CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00876512

Acronym

CALDERA-PCI

Enrollment

104

Registered

2009-04-06

Start date

2008-12-31

Completion date

2010-09-30

Last updated

2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina

Keywords

thienopyridine resistance, stable effort angina, platelet activation, ADAMTS13, von Willebrand Factor

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Platelet function tests	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.

Countries

Japan

Outcome results