CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

Stable Angina Clinical Trial

— CALDERA-PCI  

Official title:

CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876512
• Other study ID #: 0124
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: September 8, 2014
• Start date: December 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2014
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Locations

Country	Name	City	State
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet function tests	Platelet function tests and assays for blood biomarkers of coagulation activation and inflammation before, immediately after, 1, 2, and 28 days after elective PCI.	before, immediately after, 1, 2, and 28 days after elective PCI	No