ReAssessment of Anti-Platelet Therapy Using an InDividualized Strategy Based on GENetic Evaluation

2014-08-27 04:00:21 | BioPortfolio


The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using a CYP2C19*2 point-of-care genetic test.


Effective medical treatment following acute coronary syndromes and percutaneous coronary intervention (PCI) consists of dual anti-platelet therapy with aspirin and clopidogrel. Despite this treatment approach, a substantial portion of patients continue to experience an increased rate of subsequent adverse cardiovascular events including death, myocardial infarction, and stent thrombosis. This persistent vulnerability has been associated with inadequate platelet inhibition in response to clopidogrel administration, a phenomenon referred to as clopidogrel resistance. Although multiple variables have been implicated in clopidogrel resistance, mounting evidence suggests a crucial role for the loss-of-function CYP2C19*2 genetic variant. Presence of the *2 allele has been associated with a 1.5- to 6-fold increased risk of cardiovascular death, myocardial infarction, and stent thrombosis following PCI in patients treated with clopidogrel. These findings, recently bolstered by a meta-analysis, led the American Food and Drug Administration to issue a boxed warning for clopidogrel stating that poor metabolizers may not receive the full benefit of the drug. Consequently, experts have begun to advocate for routine genotyping in the context of dual anti-platelet therapy following PCI. A personalized approach to dual anti-platelet therapy following PCI is feasible given the presence of treatment alternatives such as prasugrel that are capable of overcoming clopidogrel resistance. Selective administration of prasugrel to patients at increased risk of clopidogrel resistance has the potential to successfully minimize adverse ischemic events, while simultaneously minimizing associated bleeding events and health care costs. A prospective pharmacogenomic approach to anti-platelet therapy has been previously hampered by limited access and the time-delay associated with genetic testing. The development of a point-of-care CYP2C19*2 genetic test that requires minimal training to operate carries the potential to overcome these obstacles and may facilitate the incorporation of pharmacogenomic strategies into routine clinical practice.

Patients receiving percutaneous coronary intervention in the context of non-ST elevation acute coronary syndromes and stable coronary artery disease will be randomized to either a rapid genotyping strategy or standard therapy. Patients in the Rapid Genotyping arm will be screened for the presence of the CYP2C19*2 allele using a point-of-care genetic test. Carriers of the *2 allele will receive prasugrel 10 mg daily for 1 week. Non-*2 carriers in the Rapid Genotyping arm and all patients in the Standard Therapy arm will receive clopidogrel 75 mg daily. At the end of the 1 week period, efficacy of the treatment strategies will be evaluated using VerifyNow platelet function testing.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Stable Coronary Artery Disease


Point-of-care genetic screening with subsequent prasugrel administration to CYP2C19*2 carriers


University of Ottawa Heart Institute
K1Y 4W7




University of Ottawa Heart Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T04:00:21-0400

Clinical Trials [2317 Associated Clinical Trials listed on BioPortfolio]

CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI

The studys evaluates the effect of prehospital administration of crushed tablets of Prasugrel loading dose (in addition to ASA and standard care) versus uncrushed tablets of Prasugrel load...

Pharmacological Effects of Crushing Prasugrel in STEMI Patients

Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial infarction...

Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study

Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warnin...

Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings

Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent i...

Ticagrelor vs. Prasugrel Effects on Infarct Size

This study has been designed as a randomized, double-blind trial to provide definitive evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with anterior S...

PubMed Articles [27940 Associated PubMed Articles listed on BioPortfolio]

The relationship between timing of prasugrel pretreatment and in-stent thrombus immediately after percutaneous coronary intervention for acute coronary syndrome: an optical coherence tomography study.

The optimal timing of pretreatment with prasugrel in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is unclear. We used optical coherence tomography (OCT) to compare in-ste...

Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immuno-Mycologics Lateral Flow Assay.

Cryptococcal antigen (CrAg) screening at point of care could improve cryptococcal meningitis prevention where laboratory resources are limited. We evaluated the accuracy of Immuno-Mycologics (IMMY, No...

Impact of CYP2C19 Polymorphism on Antiplatelet Potency of Prasugrel 5 and 10 mg Daily Maintenance.

Whether genetic polymorphisms (GP) impact residual platelet aggregation (RPA) following prasugrel is unclear, especially during maintenance phase. We assessed the influence of CYP2C19 GP carriers on R...

Heterogeneous Knee Effusions on Point-of-Care Ultrasound in a Toddler Diagnosed With Juvenile Idiopathic Arthritis.

Point-of-care musculoskeletal ultrasound can provide information about joint effusions and the quality of the effusion. This case report describes the findings of a previously healthy pediatric patien...

Point-of-Care Screening for Sickle-Cell Disease in Low-Resource Settings: a Multi-Center Evaluation of HemoTypeSC, a Novel Rapid Test.

Sickle cell disease is a common, life-threatening genetic disorder that is best managed when diagnosed early by newborn screening. However, sickle cell disease is most prevalent in low-resource region...

Medical and Biotech [MESH] Definitions

Allows patient diagnoses in the physician’s office, in other ambulatory setting or at bedside. The results of care are timely, and allow rapid treatment to the patient. (from NIH Fact Sheet Point-of-Care Diagnostic Testing, 2010.)

The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

Testing or screening required by federal, state, or local law or other agencies for the diagnosis of specified conditions. It is usually limited to specific populations such as categories of health care providers, members of the military, and prisoners or to specific situations such as premarital examinations or donor screening.

Identification of individuals who are heterozygous at a GENETIC LOCUS for a recessive PHENOTYPE.

Research concerned with establishing costs of nursing care, examining the relationships between nursing services and quality patient care, and viewing problems of nursing service delivery within the broader context of policy analysis and delivery of health services (from a national study, presented at the 1985 Council on Graduate Education for Administration in Nursing (CGEAN) meeting).

More From BioPortfolio on "ReAssessment of Anti-Platelet Therapy Using an InDividualized Strategy Based on GENetic Evaluation"

Quick Search


Relevant Topics

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...

Searches Linking to this Trial