CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

NCT00876512 | Completed

• 1 other identifier: 0124
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kumamoto University Hospital, Kumamoto Chuo Hospital and Saisekai Kumamoto Hospital

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kumamoto University: lead

Study Sites (1)

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

CYP2C19 gene alteration is measured by using whole blood in patients with stable effort angina undergoing PCI.

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Cardiovascular Medicine

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

JP (1)