Navigation Links
Results of rapid gene trial reported at TCT 2011
Date:11/9/2011

SAN FRANCISCO, CA NOVEMBER 9, 2011 A clinical trial of patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and stable angina showed that a strategy of rapid genotyping followed by selective administration of prasugrel to carriers of a common genetic variant (CYP2C19*2) resulted in a decreased rate of high on-treatment platelet reactivity (platelet non-responder rate) compared to standard therapy.

The investigation also demonstrated that point-of-care genetic testing is clinically feasible and is capable of facilitating rapid personalization of antiplatelet therapy. Results from the RAPID GENE trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The RAPID GENE (Reassessment of Anti-Platelet Therapy Using An Individualized Strategy Based on Genetic Evaluation) study utilized a novel point-of-care genetic test to identify carriers of the CYP2C19*2 allele and evaluated a pharmacogenetic approach to dual antiplatelet therapy following PCI.

The CYP2C19*2 allele, a common genetic variant found in up to 25% of Caucasians and 40% of Asians, is associated with increased rates of major adverse cardiovascular events (MACE) following percutaneous coronary intervention in individuals receiving clopidogrel. In March 2010, the US FDA issued a boxed warning indicating that patients carrying these genetic variants may not receive adequate protection from clopidogrel.

The RAPID GENE investigators hypothesized that a strategy of rapid genotyping followed by selective administration of prasugrel to CYP2C19*2 carriers would decrease the rate of high on-treatment platelet reactivity (platelet non-responders) compared to standard therapy. The primary objective of the study was to evaluate the first point-of-care genetic test in medicine for its accuracy and potential clinical utility.

Existing genetic testing methods are time-consuming, require laboratory expertise and cannot be performed at the clinical bedside. These limitations preclude timely identification of the CYP2C19*2 allele in patients undergoing PCI.

In the RAPID GENE study, which was conducted by a team of investigators at the University of Ottawa Heart Institute, 200 patients undergoing PCI for ACS or stable angina were randomized to a strategy of rapid point-of-care genotyping with selective administration of 10 mg of prasugrel to CYP2C19*2 carriers or to standard therapy with 75 mg of clopidogrel daily.

The study utilized the first point-of-care genetic test in medicine, which overcame many of the previous obstacles that had prevented routine clinical genetic testing. The test featured: A saliva (buccal) swab performed by clinical nurses with no prior training in genetic laboratory techniques A one step insertion of the swab into testing machine Sixty minutes to identify whether individuals carried the at-risk genetic variant.

The primary endpoint was the proportion of CYP2C19*2 carriers with impaired anti-platelet therapy response (high on-treatment platelet reactivity) in the rapid genotyping arm compared to those in the standard therapy arm after seven days. Secondary endpoints included sensitivity and specificity of the point-of-care test compared to conventional genetic testing, other measures of platelet function among CYP2C19*2 carriers and the whole cohort by randomization, MACE, and bleeding risk measured by the TIMI scale.

Enrollment of the study was completed in July 2011. In total, 187 patients completed follow-up with 91 patients in the rapid genotyping group and 96 patients in the standard therapy group.

The primary endpoint showed that the proportion of CYP219*2 carriers with high on-treatment platelet reactivity (PRU> 234) was 0% in the rapid genotyping group compared with 30.4% in the standard therapy group.

Secondary clinical outcomes showed there were no major adverse cardiovascular events in either group at seven and 30 days. There was no significant difference in TIMI major bleeding between the groups with 2.2% in the rapid genotyping group versus 1.0% in the standard therapy group.

The RAPID GENE trial demonstrated that point-of-care genetic testing following PCI performed at the bedside by clinical nurses permits accurate identification of CYP2C19*2 carriers. It further showed that point-of-care genetic testing is clinically feasible and facilitates rapid personalization of antiplatelet therapy.

"RAPID GENE is the first study to report the use of a point-of-care genetic test in medicine," said lead researcher, Derek So, MD. Dr. So is a Staff Cardiologist at the University of Ottawa Heart Institute and an Assistant Professor in the Department of Medicine at the University of Ottawa.

"These results will be integral for the application of future pharmacogenetic strategies in antiplatelet therapy in the context of percutaneous coronary intervention for acute coronary syndrome and stable angina. This represents the validation of the first point-of-care genetic test in clinical medicine. This proof-of-concept study will be applicable to all areas of medicine and will lead to larger scale trials evaluating the role pharmacogenomic treatment strategies," Dr. So said.


'/>"/>

Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. Lincare Holdings Inc. Announces Fourth Quarter and Year Ended 2009 Financial Results
2. SXC Health Solutions to Host Fiscal 2009 Fourth Quarter and Year End Results Conference Call
3. Team Health Holdings, Inc., Announces Fourth Quarter and Fiscal 2009 Financial Results
4. First blinded study of venous insufficiency prevalence in MS shows promising results
5. NEJM Publishes Trial Results Demonstrating Bard FLAIR Endovascular Stent Graft Is Superior To Balloon Angioplasty For Failing Dialysis Grafts
6. BioMed Realty Trust Reports Fourth Quarter and Full-Year 2009 Financial Results
7. Kaiser Foundation Health Plan and Hospitals Report Fourth Quarter and Fiscal Year 2009 Financial Results
8. United American Healthcare Corporation Announces Fiscal 2010 Second Quarter Results
9. Fitness Trend Towards Online Personal Training Gets Real-World Weight Loss Results on FitOrbit.com
10. Protein Sciences Corporation Announces Profitable and Cash Flow Positive Results for 2009 and Management Realignment
11. WebMD Announces Fourth Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... 23, 2017 , ... Hamlin Dental Group and Dr. Hamid Reza, dentist ... Throughout the month of February, patients who visit Hamlin Dental Group will receive a ... for two at the Cheesecake Factory. , Tickets are available for routine dental ...
(Date:2/23/2017)... ... February 23, 2017 , ... On April 13, 2017, ... on “Doping in Sport: How the Culture Might Change,” in conjunction ... The symposium will be held at Pepperdine University in Malibu, California. , Sir ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... in clinical trials, today announced that Premier Research, a leading clinical development service ... Clinical trials are becoming increasingly complex, due in part to an array of ...
(Date:2/23/2017)... ... February 23, 2017 , ... The Center for Autism ... Consortium for Autism Research and Treatment (RI-CART) and Cinemaworld to present Sensory Friendly ... (ASD) to see films in an environment that accommodates their unique needs. , ...
(Date:2/23/2017)... ... February 23, 2017 , ... Top cosmetic and periodontal ... program today with a new Indiegogo campaign . Individuals are now able ... in the Los Angeles area, either as a participating patient or through an Indiegogo ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... , 23. Februar 2017 Im Rahmen ... nationale Wirtschaftszone in der südwestlichen chinesischen Provinz Guizhou, 2017 mit ... einer Innovationsplattform aktiv an der Entwicklung einer eingebetteten Hightech-Schlüsselindustrie. ... Continue Reading ... ...
(Date:2/23/2017)... , Feb. 23, 2017 Regulus ... the discovery and development of innovative medicines targeting microRNAs, ... year 2016 financial results on Thursday, March 2, 2017 ... a conference call and webcast on March 2, 2017 ... and full year 2016 financial results and provide a ...
(Date:2/23/2017)... ... Research and Markets has announced the addition of the "Global ... report to their offering. The Global Antifungal Drugs Market ... next decade to reach approximately $12.8 billion by 2025. ... the given segments on global as well as regional levels presented in ...
Breaking Medicine Technology: