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| Sponsored by: |
Kumamoto University |
|---|---|
| Information provided by: | Kumamoto University |
| ClinicalTrials.gov Identifier: | NCT00876512 |
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: | Cohort, Prospective |
| Official Title: | CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study |
CYP2C19 gene alteration is measured by using whole blood in patients with stable effort angina undergoing PCI.
| Estimated Enrollment: | 250 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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 |
Kumamoto University Hospital, Kumamoto Chuo Hospital and Saisekai Kumamoto Hospital
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Koichi Kaikita, MD, PhD | 81-96-373-5175 | kaikitak@kumamoto-u.ac.jp |
| Contact: Hisao Ogawa, MD, PhD | 81-96-373-5175 | ogawah@kumamoto-u.ac.jp |
| Japan | |
| Kumamoto University Hospital | Recruiting |
| Kumamoto, Japan, 860-8556 | |
| Contact: Koichi Kaikita, MD, PhD 81-96-373-5175 kaikitak@kumamoto-u.ac.jp | |
| Contact: Hisao Ogawa, MD, PhD 81-96-373-5175 ogawah@kumamoto-u.ac.jp | |
| Sub-Investigator: Takamichi Ono, MD | |
More Information
| Responsible Party: | Department of Cardiovascular Medicine, Kumamoto University ( Koichi Kaikita, MD, PhD ) |
| Study ID Numbers: | 0124 |
| Study First Received: | April 3, 2009 |
| Last Updated: | April 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00876512 History of Changes |
| Health Authority: | Japan: Institutional Review Board |
|
thienopyridine resistance stable effort angina platelet activation ADAMTS13 von Willebrand Factor |
|
Von Willebrand Disease Angina Pectoris |
